FDA 510(k)

HIP SYSTEMS

K-Number: K121308 · 2012-07-30

Decision Date2012-07-30

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

HIP SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2012-07-30 under 510(k) number K121308. 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 HIP SYSTEMS?

HIP SYSTEMS is a medical device that received FDA 510(k) clearance on 2012-07-30. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K121308.

When did HIP SYSTEMS receive FDA 510(k) clearance?

HIP SYSTEMS received FDA 510(k) clearance on 2012-07-30, under 510(k) number K121308.

Who is the listed applicant for HIP SYSTEMS?

The FDA 510(k) record lists Howmedica Osteonics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HIP SYSTEMS?

The FDA product code for HIP SYSTEMS is LPH.

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Related Devices (Code: LPH)

K261453G7® Acetabular SystemZimmer Biomet K253630Mpact 3D Metal FoamMedacta International S.A.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.

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.