FDA 510(k)

NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE

K-Number: K013385 · 2002-01-09

Decision Date2002-01-09

Product CodeKRO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2002-01-09 under 510(k) number K013385. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE?

NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE is a medical device that received FDA 510(k) clearance on 2002-01-09. The listed applicant is Zimmer, Inc.. The 510(k) number is K013385.

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

NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE received FDA 510(k) clearance on 2002-01-09, under 510(k) number K013385.

Who is the listed applicant for NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE?

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 ROTATNG HINGE KNEE?

The FDA product code for NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE is KRO.

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Related Devices (Code: KRO)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.