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FDA 510(k)

ARTHREX SUTURE (UHMWPE)

K-Number: K122374 · 2012-09-25

ApplicantArthrex, Inc.
Decision Date2012-09-25
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARTHREX SUTURE (UHMWPE) is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2012-09-25 under 510(k) number K122374. 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 SUTURE (UHMWPE)?

ARTHREX SUTURE (UHMWPE) is a medical device that received FDA 510(k) clearance on 2012-09-25. The listed applicant is Arthrex, Inc.. The 510(k) number is K122374.

When did ARTHREX SUTURE (UHMWPE) receive FDA 510(k) clearance?

ARTHREX SUTURE (UHMWPE) received FDA 510(k) clearance on 2012-09-25, under 510(k) number K122374.

Who is the listed applicant for ARTHREX SUTURE (UHMWPE)?

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 SUTURE (UHMWPE)?

The FDA product code for ARTHREX SUTURE (UHMWPE) is GAT.

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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.

K262975Arthrex Beaming SystemK262618Arthrex Spine Compression FT ScrewK262451Arthrex DynaNite StaplesK262357Arthrex Bioabsorbable PushLock Suture AnchorsK260624Arthrex Radial Head Replacement SystemK260018Arthrex FiberButton

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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.

K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.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.

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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