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FDA 510(k)

ARTHREX FIBERWIRE, MODEL SPU-02NB-3800

K-Number: K010673 · 2001-05-14

ApplicantArthrex, Inc.
Decision Date2001-05-14
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARTHREX FIBERWIRE, MODEL SPU-02NB-3800 is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2001-05-14 under 510(k) number K010673. 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 FIBERWIRE, MODEL SPU-02NB-3800?

ARTHREX FIBERWIRE, MODEL SPU-02NB-3800 is a medical device that received FDA 510(k) clearance on 2001-05-14. The listed applicant is Arthrex, Inc.. The 510(k) number is K010673.

When did ARTHREX FIBERWIRE, MODEL SPU-02NB-3800 receive FDA 510(k) clearance?

ARTHREX FIBERWIRE, MODEL SPU-02NB-3800 received FDA 510(k) clearance on 2001-05-14, under 510(k) number K010673.

Who is the listed applicant for ARTHREX FIBERWIRE, MODEL SPU-02NB-3800?

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 FIBERWIRE, MODEL SPU-02NB-3800?

The FDA product code for ARTHREX FIBERWIRE, MODEL SPU-02NB-3800 is GAT.

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Other records listing Arthrex, Inc. as applicant

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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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