FDA 510(k)

Precision Casting Solutions Total Knee System

Numéro K : K190355 · 2019-05-16

DemandeurPrecision Casting Solutions, Inc.

Date de décision2019-05-16

Code produitJWH

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Precision Casting Solutions Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Precision Casting Solutions, Inc.. It received FDA 510(k) clearance on 2019-05-16 under 510(k) number K190355. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Precision Casting Solutions Total Knee System?

Precision Casting Solutions Total Knee System is a medical device that received FDA 510(k) clearance on 2019-05-16. The listed applicant is Precision Casting Solutions, Inc.. The 510(k) number is K190355.

When did Precision Casting Solutions Total Knee System receive FDA 510(k) clearance?

Precision Casting Solutions Total Knee System received FDA 510(k) clearance on 2019-05-16, under 510(k) number K190355.

Who is the listed applicant for Precision Casting Solutions Total Knee System?

The FDA 510(k) record lists Precision Casting Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Precision Casting Solutions Total Knee System?

The FDA product code for Precision Casting Solutions Total Knee System is JWH.

Essais cliniques associés

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Dispositifs connexes (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 Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

Source officielle

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