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FDA 510(k)

Arthrex LoopLoc Knotless Suture

K-Number: K212146 · 2021-10-25

ApplicantArthrex, Inc.
Decision Date2021-10-25
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Arthrex LoopLoc Knotless Suture is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2021-10-25 under 510(k) number K212146. 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 Arthrex LoopLoc Knotless Suture?

Arthrex LoopLoc Knotless Suture is a medical device that received FDA 510(k) clearance on 2021-10-25. The listed applicant is Arthrex, Inc.. The 510(k) number is K212146.

When did Arthrex LoopLoc Knotless Suture receive FDA 510(k) clearance?

Arthrex LoopLoc Knotless Suture received FDA 510(k) clearance on 2021-10-25, under 510(k) number K212146.

Who is the listed applicant for Arthrex LoopLoc Knotless Suture?

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

What is the FDA product code for Arthrex LoopLoc Knotless Suture?

The FDA product code for Arthrex LoopLoc Knotless Suture is GAT.

Related Clinical Trials

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.

NCT05753891Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective)TERMINATEDNCT06829667Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle InstabilityCOMPLETED

Other records listing Arthrex, 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.

K262357Arthrex Bioabsorbable PushLock Suture AnchorsK260624Arthrex Radial Head Replacement SystemK260018Arthrex FiberButtonK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemK253931Arthrex Bioabsorbable PushLock Suture AnchorsK254215Arthrex Beaming System

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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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