Unix 4540-0415

GUDID 07613327101522

Tibial Bearing Insert

Howmedica Osteonics Corp.

Uncoated unicondylar knee tibia prosthesis, polyethylene

• Primary Device ID: 07613327101522
• NIH Device Record Key: d53db2d5-9686-4684-857f-4384ac75e5eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unix
• Version Model Number: 4540-0415
• Catalog Number: 4540-0415
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327101522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923011

FDA Product Code

• HRY: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

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 [Unix]

• 07613327101522: Tibial Bearing Insert
• 07613327101515: Tibial Bearing Insert
• 07613327101508: Tibial Bearing Insert
• 07613327101492: Tibial Bearing Insert
• 07613327101485: Tibial Bearing Insert
• 07613327101478: Tibial Bearing Insert
• 07613327101461: Tibial Bearing Insert
• 07613327101454: Tibial Bearing Insert
• 07613327101447: Tibial Bearing Insert
• 07613327101430: Tibial Bearing Insert
• 07613327101423: Tibial Bearing Insert
• 07613327101416: Tibial Bearing Insert
• 07613327101409: Tibial Bearing Insert
• 07613327101393: Tibial Bearing Insert
• 07613327101386: Tibial Bearing Insert
• 07613327101379: Tibial Bearing Insert
• 07613327101140: Knee Femoral Component
• 07613327101133: Knee Femoral Component
• 07613327101126: Knee Femoral Component
• 07613327101119: Knee Femoral Component
• 07613327101096: Knee Femoral Component
• 07613327101072: Knee Femoral Component