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FDA 510(k)

MTF Pre-Sutured Tendon

K-Number: K181633 · 2019-03-15

ApplicantMusculoskeletal Transplant Foundation
Decision Date2019-03-15
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MTF Pre-Sutured Tendon is the device name listed in this FDA 510(k) record. The listed applicant is Musculoskeletal Transplant Foundation. It received FDA 510(k) clearance on 2019-03-15 under 510(k) number K181633. 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 MTF Pre-Sutured Tendon?

MTF Pre-Sutured Tendon is a medical device that received FDA 510(k) clearance on 2019-03-15. The listed applicant is Musculoskeletal Transplant Foundation. The 510(k) number is K181633.

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

MTF Pre-Sutured Tendon received FDA 510(k) clearance on 2019-03-15, under 510(k) number K181633.

Who is the listed applicant for MTF Pre-Sutured Tendon?

The FDA 510(k) record lists Musculoskeletal Transplant Foundation as the applicant. This does not by itself establish the device manufacturer.

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

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

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.K253145Pre-Sutured TendonRti Surgical, Inc.K253024ProZip Knotless ImplantRiverpoint Medical

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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