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FDA 510(k)

ASCENT ALL-POLY PS TIBIAL BEARINGS

K-Number: K021559 · 2002-06-05

ApplicantBiomet, Inc.
Decision Date2002-06-05
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ASCENT ALL-POLY PS TIBIAL BEARINGS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2002-06-05 under 510(k) number K021559. 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 ASCENT ALL-POLY PS TIBIAL BEARINGS?

ASCENT ALL-POLY PS TIBIAL BEARINGS is a medical device that received FDA 510(k) clearance on 2002-06-05. The listed applicant is Biomet, Inc.. The 510(k) number is K021559.

When did ASCENT ALL-POLY PS TIBIAL BEARINGS receive FDA 510(k) clearance?

ASCENT ALL-POLY PS TIBIAL BEARINGS received FDA 510(k) clearance on 2002-06-05, under 510(k) number K021559.

Who is the listed applicant for ASCENT ALL-POLY PS TIBIAL BEARINGS?

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

What is the FDA product code for ASCENT ALL-POLY PS TIBIAL BEARINGS?

The FDA product code for ASCENT ALL-POLY PS TIBIAL BEARINGS is JWH.

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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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