FDA 510(k)

Stryker Orthopaedics Hip Devices Labeling Update

K-Number: K243784 · 2025-02-06

ApplicantHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Decision Date2025-02-06

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Stryker Orthopaedics Hip Devices Labeling Update is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2025-02-06 under 510(k) number K243784. 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 Devices Labeling Update?

Stryker Orthopaedics Hip Devices Labeling Update is a medical device that received FDA 510(k) clearance on 2025-02-06. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K243784.

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

Stryker Orthopaedics Hip Devices Labeling Update received FDA 510(k) clearance on 2025-02-06, under 510(k) number K243784.

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

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

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

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

Other records listing Howmedica Osteonics Corp., Dba Stryker Orthopaedics as applicant

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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.