Triatlhlon 5533-G-516-L

GUDID 07613327671438

Tibial Bearing Insert - MS

Howmedica Osteonics Corp.

Tibial insert

• Primary Device ID: 07613327671438
• NIH Device Record Key: 18284484-6723-4b45-a6aa-cfb20dd99cf6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Triatlhlon
• Version Model Number: 5533-G-516-L
• Catalog Number: 5533-G-516-L
• Company DUNS: 058311945
• Company Name: Howmedica Osteonics Corp.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327671438 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K253637

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/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: 2026-03-06
• Device Publish Date: 2026-02-26

Devices Manufactured by Howmedica Osteonics Corp.

• 07613327660180 - Instrument: 2026-03-09 Triathlon MS Tibial Insert Trial
• 07613327648386 - Instrument: 2026-03-06 Triathlon MS Tibial Insert Trial
• 07613327648393 - Instrument: 2026-03-06 Triathlon MS Tibial Insert Trial
• 07613327648409 - Instrument: 2026-03-06 Triathlon MS Tibial Insert Trial
• 07613327648416 - Instrument: 2026-03-06 Triathlon MS Tibial Insert Trial
• 07613327648423 - Instrument: 2026-03-06 Triathlon MS Tibial Insert Trial
• 07613327648430 - Instrument: 2026-03-06 Triathlon MS Tibial Insert Trial
• 07613327648447 - Instrument: 2026-03-06 Triathlon MS Tibial Insert Trial