System12 C-M112-7-500

GUDID 37613327579797

Howmedica Osteonics Corp.

Constrained polyethylene acetabular liner

• Primary Device ID: 37613327579797
• NIH Device Record Key: 0c647c84-7091-40ce-b2d5-d27b67a07bf4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: System12
• Version Model Number: C-M112-7-500
• Catalog Number: C-M112-7-500
• Company DUNS: 058311945
• Company Name: Howmedica Osteonics Corp.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327579802 [Primary]
GS1	37613327579797 [Package]; Contains: 07613327579802; Package: pack [1 Units]; In Commercial Distribution
GS1	57613327579791 [Package]; Package: case [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063550

FDA Product Code

• KWZ: Prosthesis, hip, constrained, cemented or uncemented, metal/polymer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-25
• Device Publish Date: 2021-10-15

Devices Manufactured by Howmedica Osteonics Corp.

• 07613327644845 - INSTRUMENT: 2025-09-04 Hinge Insert Trials Tray
• 07613327659962 - INSTRUMENT: 2025-09-04 Hinge Tibial Bearing Post Trial
• 07613327524628 - TRIATHLON: 2025-09-02 Hinge Small Proximal Tibial Bearing Component
• 07613327538458 - INSTRUMENT: 2025-09-02 Hinge Trial Bearing Plate
• 07613327639544 - TRIATHLON: 2025-09-02 End Cap
• 07613327659948 - INSTRUMENT: 2025-09-02 Hinge Tibial Bearing Post Trial
• 07613327659955 - INSTRUMENT: 2025-09-02 Hinge Tibial Bearing Post Trial
• 07613327668896 - Modular Elbow: 2025-03-04 Axle Pin Assembly Large Elbow