FDA 510(k)

EVOL® ha – Hyper C Cervical Interbody Fusion System

Número K: K250605 · 2025-03-12

Data da decisão2025-03-12

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

EVOL® ha – Hyper C Cervical Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Cutting Edge Spine, LLC. It received FDA 510(k) clearance on 2025-03-12 under 510(k) number K250605. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EVOL® ha – Hyper C Cervical Interbody Fusion System?

EVOL® ha – Hyper C Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2025-03-12. The listed applicant is Cutting Edge Spine, LLC. The 510(k) number is K250605.

When did EVOL® ha – Hyper C Cervical Interbody Fusion System receive FDA 510(k) clearance?

EVOL® ha – Hyper C Cervical Interbody Fusion System received FDA 510(k) clearance on 2025-03-12, under 510(k) number K250605.

Who is the listed applicant for EVOL® ha – Hyper C Cervical Interbody Fusion System?

The FDA 510(k) record lists Cutting Edge Spine, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVOL® ha – Hyper C Cervical Interbody Fusion System?

The FDA product code for EVOL® ha – Hyper C Cervical Interbody Fusion System is ODP.

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Outros registros que listam Cutting Edge Spine, LLC como candidato(a)

K230689T-FIX™ 3DSI Joint Fusion System K214123T-FIX® 3DSI Joint Fusion System K200991EVOL Spinal Interbody System K200552EVOS Lumbar Interbody System K192497EVOL ha - D Lateral Interbody Fusion System K190025EVOL® -SI Joint Fusion 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.

Fonte oficial

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