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FDA 510(k), K053514, TRIATHLON TOTAL KNEE SYSTEM
FDA 510(k), K053514, TRIATHLON TOTAL KNEE SYSTEM
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510(K) Number: K053514
Device Name: TRIATHLON TOTAL KNEE SYSTEM
Manufacturer: TIFFANI ROGERS
Device Classification Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Regulation Number: JWH
Classification Product Code: 12/16/2005
Date Received: 01/26/2006
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: TRIATHLON TOTAL KNEE SYSTEM
Manufacturer: TIFFANI ROGERS
Device Classification Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Regulation Number: JWH
Classification Product Code: 12/16/2005
Date Received: 01/26/2006
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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