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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 a medical device manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2022-10-21 under approval 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. It is manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K222632.

When was UHR Bipolar Implants, Restoration GAP II Implants approved by the FDA?

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

What company makes UHR Bipolar Implants, Restoration GAP II Implants?

UHR Bipolar Implants, Restoration GAP II Implants is manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics.

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.

Related Clinical Trials

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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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