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FDA 510(k)

ARTHREX SUTURE GRAFTING KIT

K-Number: K041553 · 2004-12-10

ApplicantArthrex, Inc.
Decision Date2004-12-10
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARTHREX SUTURE GRAFTING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2004-12-10 under 510(k) number K041553. 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 GRAFTING KIT?

ARTHREX SUTURE GRAFTING KIT is a medical device that received FDA 510(k) clearance on 2004-12-10. The listed applicant is Arthrex, Inc.. The 510(k) number is K041553.

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

ARTHREX SUTURE GRAFTING KIT received FDA 510(k) clearance on 2004-12-10, under 510(k) number K041553.

Who is the listed applicant for ARTHREX SUTURE GRAFTING KIT?

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 GRAFTING KIT?

The FDA product code for ARTHREX SUTURE GRAFTING KIT 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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