Modular Elbow 6487-K-001

GUDID 07613327139266

Bearing, Bushing and Axle Kit

Howmedica Osteonics Corp.

Coated elbow humerus prosthesis

• Primary Device ID: 07613327139266
• NIH Device Record Key: 24287444-b761-44cb-84c1-ac03ebdc88ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Modular Elbow
• Version Model Number: 6487-K-001
• Catalog Number: 6487-K-001
• 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: true
• 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	07613327139266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062845

FDA Product Code

• HSD: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

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