21 CFR Chapter I Subchapter H โ Medical Devices โ Part 872 Dental 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 872 Dental 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
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
Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ This is a draft guidance document for the premarket notification of orthopedic non-spinal bone plates, screws, and washers.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
Facet Screw Systems - 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 document titled "Facet Screw Systems - 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 12, 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
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
Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ A guidance document titled "Classification of Posterior Cervical Screw Systems" providing guidance for industry and FDA staff on premarket 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 May 1, 2020 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2019-06024. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to classify posterior cervical screw systems into class II (special controls) and to continue to require a premarket notification (510(k)) to provide a reasonable assurance of safety andโฆ 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 April 1, 2019 Other (Public Domain) 0 reuses 0 favorites
Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2016-31670. The Food and Drug Administration (FDA) is issuing a final order to reclassify pedicle screw systems, a preamendments class III device (regulated under product code NKB), into class II (special controls), renaming the device "thoracolumbosacral pedicle screw systems";โฆ 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 30, 2016 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2016-05384. The Food and Drug Administration (FDA or Agency) is proposing to classify posterior cervical screw systems into class II (special controls) and to continue to require premarket notification to provide a reasonable assurance of safety and effectiveness of the device. Aโฆ 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 10, 2016 Other (Public Domain) 0 reuses 0 favorites
Orthopedic Devices; Reclassification of Thoracolumbosacral Rigid Pedicle Screw Systems; Classification and Effective Date of Requirement for Premarket Approval for Dynamic Stabilization Systems From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2014-26726. The Food and Drug Administration (FDA) is proposing in this administrative order to reclassify rigid pedicle screw systems, a preamendments class III device, into class II (special controls); require the filing of a premarket approval application (PMA) or a notice 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 November 12, 2014 Other (Public Domain) 0 reuses 0 favorites