FDA 510(k)

Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )

Número K: K230036 · 2023-06-23

Data da decisão2023-06-23

Código do produtoGAT

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) is the device name listed in this FDA 510(k) record. The listed applicant is Rti Surgical, Inc.. It received FDA 510(k) clearance on 2023-06-23 under 510(k) number K230036. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )?

Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is Rti Surgical, Inc.. The 510(k) number is K230036.

When did Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) receive FDA 510(k) clearance?

Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) received FDA 510(k) clearance on 2023-06-23, under 510(k) number K230036.

Who is the listed applicant for Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )?

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

What is the FDA product code for Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )?

The FDA product code for Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) is GAT.

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Dispositivos Relacionados (Código: GAT)

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Fonte oficial

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