FDA 510(k)

UHR Bipolar Implants, Restoration GAP II Implants

K-Nummer: K222632 · 2022-10-21

AntragstellerHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Entscheidungsdatum2022-10-21

ProduktcodeKWL

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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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Offizielle Quelle

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