FDA 510(k)

Pre-Sutured Tendon

K-Number: K253145 · 2025-10-22

Decision Date2025-10-22

Product CodeGAT

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Pre-Sutured Tendon is a medical device manufactured by Rti Surgical, Inc.. It received FDA 510(k) clearance on 2025-10-22 under approval number K253145. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pre-Sutured Tendon?

Pre-Sutured Tendon is a medical device that received FDA 510(k) clearance on 2025-10-22. It is manufactured by Rti Surgical, Inc.. The 510(k) number is K253145.

When was Pre-Sutured Tendon approved by the FDA?

Pre-Sutured Tendon received FDA 510(k) clearance on 2025-10-22, under approval number K253145.

What company makes Pre-Sutured Tendon?

Pre-Sutured Tendon is manufactured by Rti Surgical, Inc..

What is the FDA product code for Pre-Sutured Tendon?

The FDA product code for Pre-Sutured Tendon is GAT.

Other Devices by Rti Surgical, Inc.

K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology K163673Fortilink-C with TETRAfuse 3D Technology K230036Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCC

Related Devices (Code: GAT)

K160854MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation SutureBiomet Manafacturing Corp. K162247PERMATAPEMedos International SARL K162310XBraid TT Suture TapeStryker K161638SPEEDTRAP Graft Preparation SystemMedos International SARL K153089'cottony' II TAPE, PLEDGETSTeleflexmedical, Inc. K153087IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse CurvedIvy Sports Medicine, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.