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FDA 510(k)

ORTHOLOC 2.0/2.4 PLATE SYSTEM

K-Number: K090692 · 2009-05-08

ApplicantWrightmedicaltechnologyinc
Decision Date2009-05-08
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOLOC 2.0/2.4 PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2009-05-08 under 510(k) number K090692. 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 ORTHOLOC 2.0/2.4 PLATE SYSTEM?

ORTHOLOC 2.0/2.4 PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2009-05-08. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K090692.

When did ORTHOLOC 2.0/2.4 PLATE SYSTEM receive FDA 510(k) clearance?

ORTHOLOC 2.0/2.4 PLATE SYSTEM received FDA 510(k) clearance on 2009-05-08, under 510(k) number K090692.

Who is the listed applicant for ORTHOLOC 2.0/2.4 PLATE SYSTEM?

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

What is the FDA product code for ORTHOLOC 2.0/2.4 PLATE SYSTEM?

The FDA product code for ORTHOLOC 2.0/2.4 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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