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FDA 510(k)

DEPUY AMK 3 PEG PATELLA

K-Number: K972643 · 1998-01-21

ApplicantDepuy, Inc.
Decision Date1998-01-21
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

DEPUY AMK 3 PEG PATELLA is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1998-01-21 under 510(k) number K972643. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DEPUY AMK 3 PEG PATELLA?

DEPUY AMK 3 PEG PATELLA is a medical device that received FDA 510(k) clearance on 1998-01-21. The listed applicant is Depuy, Inc.. The 510(k) number is K972643.

When did DEPUY AMK 3 PEG PATELLA receive FDA 510(k) clearance?

DEPUY AMK 3 PEG PATELLA received FDA 510(k) clearance on 1998-01-21, under 510(k) number K972643.

Who is the listed applicant for DEPUY AMK 3 PEG PATELLA?

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

What is the FDA product code for DEPUY AMK 3 PEG PATELLA?

The FDA product code for DEPUY AMK 3 PEG PATELLA is 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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