FDA 510(k)

True Spinal Fixation System

Número K: K170710 · 2017-07-14

RequerenteInnovative Surgical Designs, Inc.

Data da decisão2017-07-14

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

True Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Surgical Designs, Inc.. It received FDA 510(k) clearance on 2017-07-14 under 510(k) number K170710. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the True Spinal Fixation System?

True Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2017-07-14. The listed applicant is Innovative Surgical Designs, Inc.. The 510(k) number is K170710.

When did True Spinal Fixation System receive FDA 510(k) clearance?

True Spinal Fixation System received FDA 510(k) clearance on 2017-07-14, under 510(k) number K170710.

Who is the listed applicant for True Spinal Fixation System?

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

What is the FDA product code for True Spinal Fixation System?

The FDA product code for True Spinal Fixation System is NKB.

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Outros registros que listam Innovative Surgical Designs, Inc. como candidato(a)

K220297True Tulip, True M.I.S.K212627True Tulip, True M.I.S.K210816True Tulip, True M.I.S.K201780True Tulip System, True M.I.S. System K181584Redi-Spine K171559True Spinal Fixation System

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Fonte oficial

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