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FDA 510(k)

ARTHREX DISTAL EXTREMITY PLATE SYSTEM

K-Number: K111253 · 2011-08-02

ApplicantArthrex, Inc.
Decision Date2011-08-02
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHREX DISTAL EXTREMITY PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2011-08-02 under 510(k) number K111253. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHREX DISTAL EXTREMITY PLATE SYSTEM?

ARTHREX DISTAL EXTREMITY PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-08-02. The listed applicant is Arthrex, Inc.. The 510(k) number is K111253.

When did ARTHREX DISTAL EXTREMITY PLATE SYSTEM receive FDA 510(k) clearance?

ARTHREX DISTAL EXTREMITY PLATE SYSTEM received FDA 510(k) clearance on 2011-08-02, under 510(k) number K111253.

Who is the listed applicant for ARTHREX DISTAL EXTREMITY PLATE SYSTEM?

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 DISTAL EXTREMITY PLATE SYSTEM?

The FDA product code for ARTHREX DISTAL EXTREMITY PLATE SYSTEM is HRS.

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Related Devices (Code: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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