FDA 510(k)

Stryker Orthopaedics Hip Systems Labeling Update

K-Number: K153345 · 2016-05-25

Decision Date2016-05-25

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Stryker Orthopaedics Hip Systems Labeling Update is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Orthopaedics. It received FDA 510(k) clearance on 2016-05-25 under 510(k) number K153345. 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 Stryker Orthopaedics Hip Systems Labeling Update?

Stryker Orthopaedics Hip Systems Labeling Update is a medical device that received FDA 510(k) clearance on 2016-05-25. The listed applicant is Stryker Orthopaedics. The 510(k) number is K153345.

When did Stryker Orthopaedics Hip Systems Labeling Update receive FDA 510(k) clearance?

Stryker Orthopaedics Hip Systems Labeling Update received FDA 510(k) clearance on 2016-05-25, under 510(k) number K153345.

Who is the listed applicant for Stryker Orthopaedics Hip Systems Labeling Update?

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

What is the FDA product code for Stryker Orthopaedics Hip Systems Labeling Update?

The FDA product code for Stryker Orthopaedics Hip Systems Labeling Update is LPH.

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Other records listing Stryker Orthopaedics as applicant

K211703Insignia Hip Stem K191414EXETER Centralizer, EXETER 2.5mm Plug K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads K173849Triathlon Total Knee System K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.