FDA 510(k)

OIC Cervical PEEK Spacer

N.º K: K160222 · 2016-12-07

SolicitanteThe Orthopaedic Implant Company

Fecha de decisión2016-12-07

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

OIC Cervical PEEK Spacer is the device name listed in this FDA 510(k) record. The listed applicant is The Orthopaedic Implant Company. It received FDA 510(k) clearance on 2016-12-07 under 510(k) number K160222. 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 OIC Cervical PEEK Spacer?

OIC Cervical PEEK Spacer is a medical device that received FDA 510(k) clearance on 2016-12-07. The listed applicant is The Orthopaedic Implant Company. The 510(k) number is K160222.

When did OIC Cervical PEEK Spacer receive FDA 510(k) clearance?

OIC Cervical PEEK Spacer received FDA 510(k) clearance on 2016-12-07, under 510(k) number K160222.

Who is the listed applicant for OIC Cervical PEEK Spacer?

The FDA 510(k) record lists The Orthopaedic Implant Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OIC Cervical PEEK Spacer?

The FDA product code for OIC Cervical PEEK Spacer is ODP.

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 The Orthopaedic Implant Company como solicitante

K242995OIC Small / Mini Fragment Plate System K182736OIC Suture Anchor System K181184OIC Intramedullary Nail System

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

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.