FDA 510(k)

OIC Cervical PEEK Spacer

Número K: K160222 · 2016-12-07

RequerenteThe Orthopaedic Implant Company

Data da decisão2016-12-07

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

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Fonte oficial

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