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FDA 510(k)

OPTILOCK PERIARTICULAR PLATING

K-Number: K092078 · 2009-08-05

ApplicantBiomet Trauma
Decision Date2009-08-05
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OPTILOCK PERIARTICULAR PLATING is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Trauma. It received FDA 510(k) clearance on 2009-08-05 under 510(k) number K092078. 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 OPTILOCK PERIARTICULAR PLATING?

OPTILOCK PERIARTICULAR PLATING is a medical device that received FDA 510(k) clearance on 2009-08-05. The listed applicant is Biomet Trauma. The 510(k) number is K092078.

When did OPTILOCK PERIARTICULAR PLATING receive FDA 510(k) clearance?

OPTILOCK PERIARTICULAR PLATING received FDA 510(k) clearance on 2009-08-05, under 510(k) number K092078.

Who is the listed applicant for OPTILOCK PERIARTICULAR PLATING?

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

What is the FDA product code for OPTILOCK PERIARTICULAR PLATING?

The FDA product code for OPTILOCK PERIARTICULAR PLATING is HRS.

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Other records listing Biomet Trauma 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.

K091976BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAILK082874BIODRIVE CANNULATED SCREW SYSTEMK081244LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONSK081243BIOMET PHOENIX ANKLE NAIL SYSTEMK071325BIOMET VARIABLE LOCKING PLATE SYSTEMK070823GROWTH CONTROL PLATING SYSTEM

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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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