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FDA 510(k)

MODULAR PROXIMALLY FLUTED HIP STEM

K-Number: K113789 · 2012-04-19

ApplicantSmith & Nephew, Inc.
Decision Date2012-04-19
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODULAR PROXIMALLY FLUTED HIP STEM 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 2012-04-19 under 510(k) number K113789. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODULAR PROXIMALLY FLUTED HIP STEM?

MODULAR PROXIMALLY FLUTED HIP STEM is a medical device that received FDA 510(k) clearance on 2012-04-19. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K113789.

When did MODULAR PROXIMALLY FLUTED HIP STEM receive FDA 510(k) clearance?

MODULAR PROXIMALLY FLUTED HIP STEM received FDA 510(k) clearance on 2012-04-19, under 510(k) number K113789.

Who is the listed applicant for MODULAR PROXIMALLY FLUTED HIP STEM?

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 MODULAR PROXIMALLY FLUTED HIP STEM?

The FDA product code for MODULAR PROXIMALLY FLUTED HIP STEM is MEH.

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Related Devices (Code: MEH)

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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.

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