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FDA 510(k)

DURATION STABILIZED UHMWPE

K-Number: K963612 · 1997-06-11

ApplicantHowmedica Corp.
Decision Date1997-06-11
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DURATION STABILIZED UHMWPE is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1997-06-11 under 510(k) number K963612. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURATION STABILIZED UHMWPE?

DURATION STABILIZED UHMWPE is a medical device that received FDA 510(k) clearance on 1997-06-11. The listed applicant is Howmedica Corp.. The 510(k) number is K963612.

When did DURATION STABILIZED UHMWPE receive FDA 510(k) clearance?

DURATION STABILIZED UHMWPE received FDA 510(k) clearance on 1997-06-11, under 510(k) number K963612.

Who is the listed applicant for DURATION STABILIZED UHMWPE?

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

What is the FDA product code for DURATION STABILIZED UHMWPE?

The FDA product code for DURATION STABILIZED UHMWPE is JDI.

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Other records listing Howmedica Corp. as applicant

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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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