FDA 510(k)

CPM Medical Consultants Tibial Revision Knee System

K-Nummer: K210695 · 2021-08-16

AntragstellerCpm Medical Consultants, LLC

Entscheidungsdatum2021-08-16

ProduktcodeJWH

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

CPM Medical Consultants Tibial Revision Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Cpm Medical Consultants, LLC. It received FDA 510(k) clearance on 2021-08-16 under 510(k) number K210695. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the CPM Medical Consultants Tibial Revision Knee System?

CPM Medical Consultants Tibial Revision Knee System is a medical device that received FDA 510(k) clearance on 2021-08-16. The listed applicant is Cpm Medical Consultants, LLC. The 510(k) number is K210695.

When did CPM Medical Consultants Tibial Revision Knee System receive FDA 510(k) clearance?

CPM Medical Consultants Tibial Revision Knee System received FDA 510(k) clearance on 2021-08-16, under 510(k) number K210695.

Who is the listed applicant for CPM Medical Consultants Tibial Revision Knee System?

The FDA 510(k) record lists Cpm Medical Consultants, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CPM Medical Consultants Tibial Revision Knee System?

The FDA product code for CPM Medical Consultants Tibial Revision Knee System is JWH.

Zugehörige klinische Studien

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Verwandte Geräte (Code: JWH)

K262057GMK ExtensionMedacta International SA K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision KniegelenkssystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

Offizielle Quelle

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