Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Origin Coxa Vara Hip Stem

K-Number: K161155 · 2016-07-19

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2016-07-19
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Origin Coxa Vara Hip Stem is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2016-07-19 under approval number K161155. 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 Origin Coxa Vara Hip Stem?

Origin Coxa Vara Hip Stem is a medical device that received FDA 510(k) clearance on 2016-07-19. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K161155.

When was Origin Coxa Vara Hip Stem approved by the FDA?

Origin Coxa Vara Hip Stem received FDA 510(k) clearance on 2016-07-19, under approval number K161155.

What company makes Origin Coxa Vara Hip Stem?

Origin Coxa Vara Hip Stem is manufactured by Signature Orthopaedics Pty, Ltd..

What is the FDA product code for Origin Coxa Vara Hip Stem?

The FDA product code for Origin Coxa Vara Hip Stem is MEH.

Other Devices by Signature Orthopaedics Pty, Ltd.

K160159Active-X Total Knee System K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner K172019Brisbane ALIF Device, Gladstone ALIF Device K172020Arlington PLIF/TLIF Cage K163625NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System K170613Genius Total Knee System

View all 42 devices →

Related Devices (Code: MEH)

K153649Exactech® Novation® Element Press-fit Femoral StemExactech, Inc. K160011H-Max S stemLima Corporate S.P.A. K160907DePuy Actis DuoFix Hip ProsthesisDepuy(Ireland) K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular LinerSignature Orthopaedics Pty, Ltd. K153772Corin TriFit TS HipCorin U.S.A. Limited K171249Entrada™ hip stemOrtho Development Corporation

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.

↑