FDA 510(k)

LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS

K-Number: K091543 · 2009-12-21

Decision Date2009-12-21

Product CodeMBH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS 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 2009-12-21 under 510(k) number K091543. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS?

LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS is a medical device that received FDA 510(k) clearance on 2009-12-21. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K091543.

When did LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS receive FDA 510(k) clearance?

LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS received FDA 510(k) clearance on 2009-12-21, under 510(k) number K091543.

Who is the listed applicant for LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS?

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 LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS?

The FDA product code for LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS is MBH.

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Related Devices (Code: MBH)

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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.