FDA 510(k)

22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads

N.º K: K234025 · 2024-04-24

SolicitanteHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Fecha de decisión2024-04-24

Código de productoLZO

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads 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 2024-04-24 under 510(k) number K234025. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads?

22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads is a medical device that received FDA 510(k) clearance on 2024-04-24. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K234025.

When did 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads receive FDA 510(k) clearance?

22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads received FDA 510(k) clearance on 2024-04-24, under 510(k) number K234025.

Who is the listed applicant for 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads?

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 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads?

The FDA product code for 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads is LZO.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Howmedica Osteonics Corp., Dba Stryker Orthopaedics como solicitante

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

Ver todos los 27 dispositivos →

Dispositivos relacionados (Código: LZO)

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG K260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbH

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.