510(K) Information Needed for Hydroxyapatite Coated Orthopedic Implants

Name: 510(K) Information Needed for Hydroxyapatite Coated Orthopedic Implants
Creator: Food and Drug Administration
Keywords: 510k,guidances,implants,orthopedic,pre-market,pre-market-requirements,requirements

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Premarket

Published

February 19, 1997

Last updated

March 18, 2020

Description

A guidance document providing information on the premarket requirements for hydroxyapatite coated orthopedic implants.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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1 Main file

510(K) Information Needed for Hydroxyapatite Coated Orthopedic Implants

Updated on March 18, 2020

none

URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-information-needed-hydroxyapatite-coated-orthopedic-implants
Permalink: https://data.openrid.co/en/datasets/r/7994798a-e584-49bd-9ec0-bbbf45647bc8
MIME Type: None

Created on: February 19, 1997
Modified on: March 18, 2020

510(K) Information Needed for Hydroxyapatite Coated Orthopedic Implants

Information

Type

Regulated products

Topics

Published

Last updated

Description

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Organization

Country / Region

License

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