FDA 510(k)

IdentiTi II Cervical Interbody System

Número K: K251080 · 2025-07-03

Data da decisão2025-07-03

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

IdentiTi II Cervical Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2025-07-03 under 510(k) number K251080. 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 IdentiTi II Cervical Interbody System?

IdentiTi II Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2025-07-03. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K251080.

When did IdentiTi II Cervical Interbody System receive FDA 510(k) clearance?

IdentiTi II Cervical Interbody System received FDA 510(k) clearance on 2025-07-03, under 510(k) number K251080.

Who is the listed applicant for IdentiTi II Cervical Interbody System?

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

What is the FDA product code for IdentiTi II Cervical Interbody System?

The FDA product code for IdentiTi II Cervical Interbody System is ODP.

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Outros registros que listam Alphatec Spine, Inc. como candidato(a)

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Fonte oficial

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