System12 C-M112-7-500

GUDID 37613327579797

Howmedica Osteonics Corp.

Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner 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.

• 07613327564815 - INSTRUMENT: 2024-03-21 Exeter X3 RimFit Cups Template (7309)
• 07613327565874 - INSTRUMENT: 2024-03-21 Restoration Modular Revision Hip System - Conical Distal Stem (Straight) 115mm Template
• 07613327404876 - INSTRUMENT: 2023-11-10 Triathlon Pro Femoral Trial
• 07613327404883 - INSTRUMENT: 2023-11-10 Triathlon Pro PS Anterior Bushing
• 07613327404890 - INSTRUMENT: 2023-11-10 Triathlon Pro PS Anterior Bushing
• 07613327404906 - INSTRUMENT: 2023-11-10 Triathlon Pro Modular PS Box Trial
• 07613327404913 - INSTRUMENT: 2023-11-10 Triathlon Pro PS Box Cut Protector
• 07613327404920 - INSTRUMENT: 2023-11-10 Triathlon Pro Modular PS Box Trial