FDA 510(k)

HAtetracell™-C Titanium Cervical IBF System

N.º K: K231899 · 2023-10-17

Fecha de decisión2023-10-17

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

HAtetracell™-C Titanium Cervical IBF System is the device name listed in this FDA 510(k) record. The listed applicant is Innovasis, Inc.. It received FDA 510(k) clearance on 2023-10-17 under 510(k) number K231899. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the HAtetracell™-C Titanium Cervical IBF System?

HAtetracell™-C Titanium Cervical IBF System is a medical device that received FDA 510(k) clearance on 2023-10-17. The listed applicant is Innovasis, Inc.. The 510(k) number is K231899.

When did HAtetracell™-C Titanium Cervical IBF System receive FDA 510(k) clearance?

HAtetracell™-C Titanium Cervical IBF System received FDA 510(k) clearance on 2023-10-17, under 510(k) number K231899.

Who is the listed applicant for HAtetracell™-C Titanium Cervical IBF System?

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

What is the FDA product code for HAtetracell™-C Titanium Cervical IBF System?

The FDA product code for HAtetracell™-C Titanium Cervical IBF System is ODP.

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Otros registros que enlistan a Innovasis, Inc. como solicitante

K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)K250182Innovasis Navigation Instruments K241276Vector™ Pedicle Screw System K223511Excella Navigation Instruments K223510Matrix HA Fusion Porous Cervical IBF System K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF System

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Dispositivos relacionados (Código: ODP)

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker Spine K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.

Fuente oficial

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