FDA 510(k)

Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head

K-Number: K191708 · 2020-08-14

ApplicantSignature Orthopaedics Pty, Ltd.

Decision Date2020-08-14

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2020-08-14 under approval number K191708. 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 Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head?

Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head is a medical device that received FDA 510(k) clearance on 2020-08-14. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K191708.

When was Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head approved by the FDA?

Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head received FDA 510(k) clearance on 2020-08-14, under approval number K191708.

What company makes Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head?

Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head is manufactured by Signature Orthopaedics Pty, Ltd..

What is the FDA product code for Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head?

The FDA product code for Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head is LPH.

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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.