FDA 510(k)

SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE

K-Number: K042515 · 2005-03-14

Decision Date2005-03-14

Product CodeJWH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE 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 2005-03-14 under 510(k) number K042515. 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 SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE?

SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE is a medical device that received FDA 510(k) clearance on 2005-03-14. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K042515.

When did SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE receive FDA 510(k) clearance?

SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE received FDA 510(k) clearance on 2005-03-14, under 510(k) number K042515.

Who is the listed applicant for SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE?

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 SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE?

The FDA product code for SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE is JWH.

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Other records listing Smith & Nephew, Inc. as applicant

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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.