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FDA 510(k)

NEXGEN COMPLETE KNEE SOLUTION

K-Number: K963148 · 1997-02-13

ApplicantZimmer, Inc.
Decision Date1997-02-13
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEXGEN COMPLETE KNEE SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1997-02-13 under 510(k) number K963148. 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 NEXGEN COMPLETE KNEE SOLUTION?

NEXGEN COMPLETE KNEE SOLUTION is a medical device that received FDA 510(k) clearance on 1997-02-13. The listed applicant is Zimmer, Inc.. The 510(k) number is K963148.

When did NEXGEN COMPLETE KNEE SOLUTION receive FDA 510(k) clearance?

NEXGEN COMPLETE KNEE SOLUTION received FDA 510(k) clearance on 1997-02-13, under 510(k) number K963148.

Who is the listed applicant for NEXGEN COMPLETE KNEE SOLUTION?

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

What is the FDA product code for NEXGEN COMPLETE KNEE SOLUTION?

The FDA product code for NEXGEN COMPLETE KNEE SOLUTION is JWH.

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Other records listing Zimmer, Inc. as applicant

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Related Devices (Code: JWH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION 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.

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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