FDA 510(k)

ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT

K-Number: K121636 · 2012-10-24

Decision Date2012-10-24

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT is the device name listed in this FDA 510(k) record. The listed applicant is Tgm Medical, Inc.. It received FDA 510(k) clearance on 2012-10-24 under 510(k) number K121636. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT?

ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT is a medical device that received FDA 510(k) clearance on 2012-10-24. The listed applicant is Tgm Medical, Inc.. The 510(k) number is K121636.

When did ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT receive FDA 510(k) clearance?

ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT received FDA 510(k) clearance on 2012-10-24, under 510(k) number K121636.

Who is the listed applicant for ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT?

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

What is the FDA product code for ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT?

The FDA product code for ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT is LPH.

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Other records listing Tgm Medical, Inc. as applicant

K130084MILESTONE REVISION KNEE SYSTEM (MRKS) - FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, STEMS, FEMORAL & TIBIAL AUGM K121509TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT K112285MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZED, UNOCATED / RLP, UNCOATED; TIBIAL INSERT / BASEPLATE...

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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.