FDA 510(k)

SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD

K-Number: K062408 · 2006-09-12

Decision Date2006-09-12

Product CodeKWL

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD 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 2006-09-12 under 510(k) number K062408. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD?

SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD is a medical device that received FDA 510(k) clearance on 2006-09-12. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K062408.

When did SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD receive FDA 510(k) clearance?

SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD received FDA 510(k) clearance on 2006-09-12, under 510(k) number K062408.

Who is the listed applicant for SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD?

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 MODULAR FEMORAL (HEMI) HEAD?

The FDA product code for SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD is KWL.

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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.