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FDA 510(k)

Identity Imprint Knee Replacement System

K-Number: K210191 · 2021-05-06

ApplicantConformis, Inc.
Decision Date2021-05-06
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Identity Imprint Knee Replacement System is a medical device manufactured by Conformis, Inc.. It received FDA 510(k) clearance on 2021-05-06 under approval number K210191. 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 Identity Imprint Knee Replacement System?

Identity Imprint Knee Replacement System is a medical device that received FDA 510(k) clearance on 2021-05-06. It is manufactured by Conformis, Inc.. The 510(k) number is K210191.

When was Identity Imprint Knee Replacement System approved by the FDA?

Identity Imprint Knee Replacement System received FDA 510(k) clearance on 2021-05-06, under approval number K210191.

What company makes Identity Imprint Knee Replacement System?

Identity Imprint Knee Replacement System is manufactured by Conformis, Inc..

What is the FDA product code for Identity Imprint Knee Replacement System?

The FDA product code for Identity Imprint Knee Replacement System is JWH.

Related Clinical Trials

NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT07601269 Replacement of the Native Mitral Valve Using the ReValve System RECRUITING NCT06414265 Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation RECRUITING NCT06608823 ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™ RECRUITING NCT03242642 Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation. RECRUITING NCT07276711 CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material RECRUITING

Other Devices by Conformis, Inc.

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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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