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FDA 510(k)

CALCANEAL FRACTURE PLATE SYSTEM

K-Number: K090582 · 2009-07-02

ApplicantTornier, Inc.
Decision Date2009-07-02
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CALCANEAL FRACTURE PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2009-07-02 under 510(k) number K090582. 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 CALCANEAL FRACTURE PLATE SYSTEM?

CALCANEAL FRACTURE PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2009-07-02. The listed applicant is Tornier, Inc.. The 510(k) number is K090582.

When did CALCANEAL FRACTURE PLATE SYSTEM receive FDA 510(k) clearance?

CALCANEAL FRACTURE PLATE SYSTEM received FDA 510(k) clearance on 2009-07-02, under 510(k) number K090582.

Who is the listed applicant for CALCANEAL FRACTURE PLATE SYSTEM?

The FDA 510(k) record lists Tornier, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CALCANEAL FRACTURE PLATE SYSTEM?

The FDA product code for CALCANEAL FRACTURE PLATE SYSTEM is HRS.

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Other records listing Tornier, 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.

K260721Tornier Perform Advanced GlenoidK252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)K230352Tornier Humeral Nail and Tornier Long Humeral NailK220914Tornier Perform Humeral System – FractureK220418Tornier Perform Humeral System – Stemless

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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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