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FDA 510(k)

Pre-Sutured Tendon

K-Number: K253145 · 2025-10-22

ApplicantRti Surgical, Inc.
Decision Date2025-10-22
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Pre-Sutured Tendon 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 2025-10-22 under 510(k) 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. The listed applicant is Rti Surgical, Inc.. The 510(k) number is K253145.

When did Pre-Sutured Tendon receive FDA 510(k) clearance?

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

Who is the listed applicant for Pre-Sutured Tendon?

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?

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

Other records listing Rti Surgical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCK230036Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyK163673Fortilink™-C with TETRAfuse™ 3D Technology

Related Devices (Code: GAT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253024ProZip Knotless ImplantRiverpoint MedicalK252225PowerKnot High Strength SuturesMedacta International S.A.

Official Source

View on FDA Database →

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

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