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FDA 510(k)

ARTHREX BIO-SUTURE

K-Number: K112899 · 2012-04-06

ApplicantArthrex, Inc.
Decision Date2012-04-06
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARTHREX BIO-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 2012-04-06 under 510(k) number K112899. 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 BIO-SUTURE?

ARTHREX BIO-SUTURE is a medical device that received FDA 510(k) clearance on 2012-04-06. The listed applicant is Arthrex, Inc.. The 510(k) number is K112899.

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

ARTHREX BIO-SUTURE received FDA 510(k) clearance on 2012-04-06, under 510(k) number K112899.

Who is the listed applicant for ARTHREX BIO-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 BIO-SUTURE?

The FDA product code for ARTHREX BIO-SUTURE 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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