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FDA 510(k)

GEM INSET PATELLAR COMPONENT

K-Number: K032950 · 2003-12-19

ApplicantKinamed, Inc.
Decision Date2003-12-19
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GEM INSET PATELLAR COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Kinamed, Inc.. It received FDA 510(k) clearance on 2003-12-19 under 510(k) number K032950. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEM INSET PATELLAR COMPONENT?

GEM INSET PATELLAR COMPONENT is a medical device that received FDA 510(k) clearance on 2003-12-19. The listed applicant is Kinamed, Inc.. The 510(k) number is K032950.

When did GEM INSET PATELLAR COMPONENT receive FDA 510(k) clearance?

GEM INSET PATELLAR COMPONENT received FDA 510(k) clearance on 2003-12-19, under 510(k) number K032950.

Who is the listed applicant for GEM INSET PATELLAR COMPONENT?

The FDA 510(k) record lists Kinamed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEM INSET PATELLAR COMPONENT?

The FDA product code for GEM INSET PATELLAR COMPONENT is JWH.

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Other records listing Kinamed, Inc. as applicant

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Related Devices (Code: JWH)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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