21 CFR Chapter I Subchapter H โ Medical Devices โ Part 888 Orthopedic Devices From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ Part 888 Orthopedic Devices". Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 77.77777777777779/100 Updated 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Orthopedic Devices; Classification of the Intervertebral Body Graft Containment Device From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2024-19726. The Food and Drug Administration (FDA, Agency, or we) is classifying the intervertebral body graft containment device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codifiedโฆ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ This document is a draft guidance for the industry and FDA staff on the characterization of metallic and calcium phosphate coatings on orthopedic devices. It falls under the premarket topic. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on January 22, 2024 Other (Public Domain) 0 reuses 0 favorites
Patient-Matched Guides to Orthopedic Implants: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ This document is a draft guidance for industry and FDA staff on patient-matched guides to orthopedic implants in the premarket phase. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 28, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2023-06566. The Food and Drug Administration (FDA or Agency) is issuing a final rule to classify spinal spheres for use in intervertebral fusion procedures (an unclassified, preamendments device) into class III for which FDA is separately requiring the filing of a premarketโฆ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 30, 2023 Other (Public Domain) 0 reuses 0 favorites
Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ This is a draft guidance document for the premarket notification of orthopedic non-spinal bone plates, screws, and washers. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 28, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Orthopedic Devices; Classification of the Resorbable Shoulder Spacer From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2023-00012. The Food and Drug Administration (FDA, Agency, or we) is classifying the resorbable shoulder spacer into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for theโฆ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 6, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Orthopedic Devices; Classification of the Implantable Post-Surgical Kinematic Measurement Knee Device From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2022-28604. The Food and Drug Administration (FDA, Agency or we) is classifying the implantable post-surgical kinematic measurement knee device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of theโฆ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 5, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Orthopedic Devices; Classification of the Bone Indentation Device From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2022-28601. The Food and Drug Administration (FDA, Agency, or we) is classifying the bone indentation device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the boneโฆ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 5, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Orthopedic Devices; Classification of the Resorbable Implant for Anterior Cruciate Ligament (ACL) Repair From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2022-28166. The Food and Drug Administration (FDA, Agency, or we) is classifying the resorbable implant for anterior cruciate ligament (ACL) repair into class II (special controls). The special controls that apply to the device type are identified in this order and will be part ofโฆ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on December 29, 2022 Other (Public Domain) 0 reuses 0 favorites
Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ This is a guidance document titled "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway" for premarket review. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 8, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Orthopedic Devices; Classification of the Screw Sleeve Bone Fixation Device From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2022-04154. The Food and Drug Administration (FDA, Agency, or we) is classifying the screw sleeve bone fixation device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for theโฆ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 1, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2021-27137. The Food and Drug Administration (FDA or Agency) is proposing to classify spinal spheres for use in intervertebral fusion procedures (an unclassified, preamendments device) into class III for which FDA is separately proposing to require the filing of a premarketโฆ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on December 15, 2021 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Orthopedic Devices; Classification of the Intraoperative Orthopedic Strain Sensor From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2021-26183. The Food and Drug Administration (FDA or we) is classifying the intraoperative orthopedic strain sensor into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for theโฆ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on December 2, 2021 Other (Public Domain) 0 reuses 0 favorites
Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ This document is a guidance for the industry and FDA staff on safety and performance criteria for orthopedic non-spinal metallic bone screws and washers. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on December 10, 2020 Other (Public Domain) 0 reuses 0 favorites
Reviewers Guidance Checklist For Orthopedic External Fixation Devices Version #5 From Food and Drug Administration (FDA) ๐บ๐ธ A guidance document titled "Reviewers Guidance Checklist For Orthopedic External Fixation Devices Version #5" for premarket assessment. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 19, 2020 Other (Public Domain) 0 reuses 0 favorites
Clinical Data Presentations for Orthopedic Device Applications - Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) ๐บ๐ธ This document is a guidance document titled "Clinical Data Presentations for Orthopedic Device Applications" for premarket orthopedic device applications. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 19, 2020 Other (Public Domain) 0 reuses 0 favorites
Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements - Guidance for Industry and for FDA Reviewers/Staff From Food and Drug Administration (FDA) ๐บ๐ธ This document provides guidance on testing metallic plasma sprayed coatings on orthopedic implants for postmarket surveillance requirements. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 18, 2020 Other (Public Domain) 0 reuses 0 favorites
510(K) Information Needed for Hydroxyapatite Coated Orthopedic Implants From Food and Drug Administration (FDA) ๐บ๐ธ A guidance document providing information on the premarket requirements for hydroxyapatite coated orthopedic implants. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 18, 2020 Other (Public Domain) 0 reuses 0 favorites
Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone Or Bone Cement From Food and Drug Administration (FDA) ๐บ๐ธ A guidance document for premarket testing of orthopedic implants with modified metallic surfaces apposing bone or bone cement. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 17, 2020 Other (Public Domain) 0 reuses 0 favorites