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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 the device name listed in this FDA 510(k) record. The listed applicant is Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2016-07-19 under 510(k) 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. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K161155.

When did Origin Coxa Vara Hip Stem receive FDA 510(k) clearance?

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

Who is the listed applicant for Origin Coxa Vara Hip Stem?

The FDA 510(k) record lists Signature Orthopaedics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Signature Orthopaedics Pty, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MEH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261576Icona Hip StemCorin, Ltd.K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KGK251166Mfinity Femoral SystemMedacta International S.A.K251052Trivicta® Hip StemOrtho Development Corp.K242315Resolve Modular Revision Hip StemUnited Orthopedic CorporationK243839Alteon® HA Femoral StemsExactech, Inc.

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.

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