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FDA 510(k)

LOSPA II Knee System (EXULT Knee Replacement System)

K-Number: K200395 · 2020-05-07

ApplicantCorentec Co., Ltd.
Decision Date2020-05-07
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LOSPA II Knee System (EXULT Knee Replacement System) is a medical device manufactured by Corentec Co., Ltd.. It received FDA 510(k) clearance on 2020-05-07 under approval number K200395. 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 LOSPA II Knee System (EXULT Knee Replacement System)?

LOSPA II Knee System (EXULT Knee Replacement System) is a medical device that received FDA 510(k) clearance on 2020-05-07. It is manufactured by Corentec Co., Ltd.. The 510(k) number is K200395.

When was LOSPA II Knee System (EXULT Knee Replacement System) approved by the FDA?

LOSPA II Knee System (EXULT Knee Replacement System) received FDA 510(k) clearance on 2020-05-07, under approval number K200395.

What company makes LOSPA II Knee System (EXULT Knee Replacement System)?

LOSPA II Knee System (EXULT Knee Replacement System) is manufactured by Corentec Co., Ltd..

What is the FDA product code for LOSPA II Knee System (EXULT Knee Replacement System)?

The FDA product code for LOSPA II Knee System (EXULT 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 Corentec Co., Ltd.

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup System K160157LOSPA Modular Knee System K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug K172806Bencox Mirabo Cup System K170243LOSPA IS TLIF & DLIF Cages K161641LOSPA IS ACP System

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Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

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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