FDA 510(k)

True Tulip, True M.I.S.

Número K: K212627 · 2022-02-18

RequerenteInnovative Surgical Designs, Inc.

Data da decisão2022-02-18

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

True Tulip, True M.I.S. 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 2022-02-18 under 510(k) number K212627. 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 Tulip, True M.I.S.?

True Tulip, True M.I.S. is a medical device that received FDA 510(k) clearance on 2022-02-18. The listed applicant is Innovative Surgical Designs, Inc.. The 510(k) number is K212627.

When did True Tulip, True M.I.S. receive FDA 510(k) clearance?

True Tulip, True M.I.S. received FDA 510(k) clearance on 2022-02-18, under 510(k) number K212627.

Who is the listed applicant for True Tulip, True M.I.S.?

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 Tulip, True M.I.S.?

The FDA product code for True Tulip, True M.I.S. is NKB.

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

K220297True 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 K170710True Spinal Fixation System

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Fonte oficial

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