Bearing and Axle Bushing Assembly - Standard Elbow C-M113-1-301

GUDID 37613327590075

Howmedica Osteonics Corp.

Coated elbow humerus prosthesis

• Primary Device ID: 37613327590075
• NIH Device Record Key: e477eb43-a3b7-4b4c-96ba-cb16661a09ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bearing and Axle Bushing Assembly - Standard Elbow
• Version Model Number: C-M113-1-301
• Catalog Number: C-M113-1-301
• 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	07613327590074 [Primary]
GS1	37613327590075 [Package]; Contains: 07613327590074; Package: pack [1 Units]; In Commercial Distribution
GS1	57613327590079 [Package]; Package: case [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980502

FDA Product Code

• JDC: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

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: 2022-03-31
• Device Publish Date: 2022-03-23

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