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FDA 510(k)

TEXAS T - PLATE

K-Number: K031334 · 2003-05-22

ApplicantBiomet, Inc.
Decision Date2003-05-22
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TEXAS T - PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2003-05-22 under 510(k) number K031334. 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 TEXAS T - PLATE?

TEXAS T - PLATE is a medical device that received FDA 510(k) clearance on 2003-05-22. The listed applicant is Biomet, Inc.. The 510(k) number is K031334.

When did TEXAS T - PLATE receive FDA 510(k) clearance?

TEXAS T - PLATE received FDA 510(k) clearance on 2003-05-22, under 510(k) number K031334.

Who is the listed applicant for TEXAS T - PLATE?

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

What is the FDA product code for TEXAS T - PLATE?

The FDA product code for TEXAS T - PLATE 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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