FDA 510(k)

UHR Bipolar Implants, Restoration GAP II Implants

K-Number: K222632 · 2022-10-21

ApplicantHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Decision Date2022-10-21

Product CodeKWL

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

UHR Bipolar Implants, Restoration GAP II Implants is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2022-10-21 under 510(k) number K222632. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UHR Bipolar Implants, Restoration GAP II Implants?

UHR Bipolar Implants, Restoration GAP II Implants is a medical device that received FDA 510(k) clearance on 2022-10-21. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K222632.

When did UHR Bipolar Implants, Restoration GAP II Implants receive FDA 510(k) clearance?

UHR Bipolar Implants, Restoration GAP II Implants received FDA 510(k) clearance on 2022-10-21, under 510(k) number K222632.

Who is the listed applicant for UHR Bipolar Implants, Restoration GAP II Implants?

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

What is the FDA product code for UHR Bipolar Implants, Restoration GAP II Implants?

The FDA product code for UHR Bipolar Implants, Restoration GAP II Implants is KWL.

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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.