Modular Elbow C-MM100639-04

GUDID 07613327668896

Axle Pin Assembly Large Elbow

Howmedica Osteonics Corp.

Coated elbow humerus prosthesis

• Primary Device ID: 07613327668896
• NIH Device Record Key: e142bc2b-ede3-44b4-8ea1-a7200bc5fddb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Modular Elbow
• Version Model Number: C-MM100639-04
• Catalog Number: C-MM100639-04
• 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	07613327139211 [Previous]
GS1	07613327668896 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062845

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: 2025-03-04
• Device Publish Date: 2025-02-24

On-Brand Devices [Modular Elbow]

• 07613327139303: Humeral Assembly
• 07613327139266: Bearing, Bushing and Axle Kit
• 07613327139211: Humeral Assembly
• 07613327139204: Total Humeral Component
• 07613327139198: Humeral Assembly
• 07613327139181: Humeral Assembly
• 07613327139167: Total Humeral Component
• 07613327138498: Ulna Component
• 07613327138481: Ulna Component
• 07613327138474: Ulna Component
• 07613327138467: Ulna Component
• 07613327138450: Ulna Component
• 07613327138412: Ulna Component
• 07613327668896: Axle Pin Assembly Large Elbow