FDA 510(k)

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

N.º K: K230036 · 2023-06-23

Fecha de decisión2023-06-23

Código de productoGAT

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Rti Surgical, Inc. como solicitante

K253145Pre-Sutured Tendon K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCC K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology K163673Fortilink™-C with TETRAfuse™ 3D Technology

Dispositivos relacionados (Código: GAT)

K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC K254275HyperSuture All Green Extension LineThreadstone, LLC K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, Inc.

Fuente oficial

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