FDA 510(k)

Stryker Orthopaedics Hip Systems Labeling Update

Numéro K : K233498 · 2023-12-21

DemandeurHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Date de décision2023-12-21

Code produitLPH

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Stryker Orthopaedics Hip Systems 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 2023-12-21 under 510(k) number K233498. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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 2023-12-21. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K233498.

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 2023-12-21, under 510(k) number K233498.

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

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

Essais cliniques associés

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Autres dossiers indiquant Howmedica Osteonics Corp., Dba Stryker Orthopaedics en tant que demandeur

K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System 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 Component K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper K252044Triathlon® Total Knee System - Triathlon® Gold Femoral Components K251665Triathlon® Hinge Knee System

Voir tous les 27 dispositifs →

Dispositifs connexes (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.

Source officielle

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