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FDA PMA

Prosthesis, spinous process tension band implant

Número do PMA: P220031 · 2026-04-08

RequerenteEmpirical Spine, Inc.
Data da decisão2026-04-08
Número PMAP220031
Código do produtoSGK
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoOR

Resumo do dispositivo

Prosthesis, spinous process tension band implant is the device name listed in this FDA 510(k) record. The listed applicant is Empirical Spine, Inc.. It received FDA 510(k) clearance on 2026-04-08. The device is classified under product code SGK. It was reviewed by the OR advisory panel.

Perguntas frequentes

What is the Prosthesis, spinous process tension band implant?

Prosthesis, spinous process tension band implant is a medical device that received FDA 510(k) clearance on 2026-04-08. The listed applicant is Empirical Spine, Inc..

When did Prosthesis, spinous process tension band implant receive FDA 510(k) clearance?

The clearance date for Prosthesis, spinous process tension band implant can be found in the official FDA records.

Who is the listed applicant for Prosthesis, spinous process tension band implant?

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

What is the FDA product code for Prosthesis, spinous process tension band implant?

The FDA product code for Prosthesis, spinous process tension band implant is SGK.

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Fonte oficial

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