FDA 510(k)

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component

Numéro K : K241716 · 2024-08-02

DemandeurHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Date de décision2024-08-02

Code produitJDI

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component 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 2024-08-02 under 510(k) number K241716. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component?

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K241716.

When did Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component receive FDA 510(k) clearance?

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component received FDA 510(k) clearance on 2024-08-02, under 510(k) number K241716.

Who is the listed applicant for Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component?

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 Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component?

The FDA product code for Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component is JDI.

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

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Dispositifs connexes (Code : JDI)

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Source officielle

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