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FDA 510(k)

GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM

K-Number: K073286 · 2008-03-07

ApplicantZimmer, Inc.
Decision Date2008-03-07
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2008-03-07 under 510(k) number K073286. 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 GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM?

GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM is a medical device that received FDA 510(k) clearance on 2008-03-07. The listed applicant is Zimmer, Inc.. The 510(k) number is K073286.

When did GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM receive FDA 510(k) clearance?

GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM received FDA 510(k) clearance on 2008-03-07, under 510(k) number K073286.

Who is the listed applicant for GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM?

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 GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM?

The FDA product code for GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM is JWH.

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Related Devices (Code: JWH)

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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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