Triathlon 5537-G-725-E

GUDID 07613327287820

Total Stabilizer+ Tibial Insert

Howmedica Osteonics Corp.

Tibial insert

• Primary Device ID: 07613327287820
• NIH Device Record Key: 6cf0577c-ec57-4ad2-a268-0dbae6cc74fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Triathlon
• Version Model Number: 5537-G-725-E
• Catalog Number: 5537-G-725-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: false
• 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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327287820 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172634

FDA Product Code

• MBH: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, 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: 2018-07-30
• Device Publish Date: 2018-06-27

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