FDA 510(k)

PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT

K-Number: K051229 · 2005-07-20

Decision Date2005-07-20

Product CodeJWH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2005-07-20 under 510(k) number K051229. 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 PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT?

PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT is a medical device that received FDA 510(k) clearance on 2005-07-20. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K051229.

When did PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT receive FDA 510(k) clearance?

PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT received FDA 510(k) clearance on 2005-07-20, under 510(k) number K051229.

Who is the listed applicant for PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT?

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

What is the FDA product code for PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT?

The FDA product code for PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT is JWH.

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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.