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 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 2020-08-14 under 510(k) 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. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K191708.

When did Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head receive FDA 510(k) clearance?

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

Who is the listed applicant for Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head?

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 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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Related Devices (Code: LPH)

K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC K251270Taperloc® Complete Hip StemBiomet, Inc.K252623G7® Revision Acetabular SystemZimmer, Inc.K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.

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.