Triathlon 5532-G-812-E

GUDID 07613327391664

Tibial Bearing Insert - PS

Howmedica Osteonics Corp.

Tibial insert

• Primary Device ID: 07613327391664
• NIH Device Record Key: 3f047e47-1317-4392-b64e-c0358ba63b0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Triathlon
• Version Model Number: 5532-G-812-E
• Catalog Number: 5532-G-812-E
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327391664 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173849

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: 2019-01-14
• Device Publish Date: 2018-12-13

On-Brand Devices [Triathlon]

• 07613327392517: Tibial Bearing Insert - CS
• 07613327392500: Tibial Bearing Insert - CS
• 07613327392494: Tibial Bearing Insert - PS
• 07613327392487: Tibial Bearing Insert - PS
• 07613327392463: Tibial Bearing Insert - CR
• 07613327392456: Tibial Bearing Insert - PS
• 07613327392449: Tibial Bearing Insert - CS
• 07613327392432: Tibial Bearing Insert - CR
• 07613327392425: Tibial Bearing Insert - PS
• 07613327392401: Tibial Bearing Insert - CR
• 07613327392395: Tibial Bearing Insert - PS
• 07613327392371: Tibial Bearing Insert - CS
• 07613327392364: Tibial Bearing Insert - CS
• 07613327392357: Tibial Bearing Insert - CS
• 07613327392340: Tibial Bearing Insert - CS
• 07613327392333: Tibial Bearing Insert - PS
• 07613327392326: Tibial Bearing Insert - CS
• 07613327392289: Tibial Bearing Insert - PS
• 07613327392272: Tibial Bearing Insert - CS
• 07613327392265: Tibial Bearing Insert - PS
• 07613327392258: Tibial Bearing Insert - CR
• 07613327392241: Tibial Bearing Insert - PS
• 07613327392234: Tibial Bearing Insert - CS
• 07613327392227: Tibial Bearing Insert - PS
• 07613327392210: Tibial Bearing Insert - PS
• 07613327392180: Tibial Bearing Insert - PS
• 07613327392173: Tibial Bearing Insert - PS
• 07613327392166: Tibial Bearing Insert - CR
• 07613327392159: Tibial Bearing Insert - PS
• 07613327392142: Tibial Bearing Insert - PS
• 07613327392111: Tibial Bearing Insert - CR
• 07613327392104: Tibial Bearing Insert - PS
• 07613327392098: Tibial Bearing Insert - PS
• 07613327392081: Tibial Bearing Insert - PS
• 07613327392074: Tibial Bearing Insert - PS
• 07613327392067: Tibial Bearing Insert - CS
• 07613327392036: Tibial Bearing Insert - PS
• 07613327392029: Tibial Bearing Insert - CR
• 07613327392012: Tibial Bearing Insert - CS
• 07613327392005: Tibial Bearing Insert - CS
• 07613327391992: Tibial Bearing Insert - CR
• 07613327391978: Tibial Bearing Insert - PS
• 07613327391961: Tibial Bearing Insert - PS
• 07613327391954: Tibial Bearing Insert - PS
• 07613327391947: Tibial Bearing Insert - CS
• 07613327391930: Tibial Bearing Insert - CS
• 07613327391916: Tibial Bearing Insert - CS
• 07613327391909: Tibial Bearing Insert - CR
• 07613327391893: Tibial Bearing Insert - CS
• 07613327391886: Tibial Bearing Insert - CS