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FDA 510(k), K123486, TRIATHLON TRITANIUM TIBIAL BASEPLATE
FDA 510(k), K123486, TRIATHLON TRITANIUM TIBIAL BASEPLATE
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510(K) Number: K123486
Device Name: TRIATHLON TRITANIUM TIBIAL BASEPLATE
Manufacturer: AUDREY WITKO
Device Classification Name: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Regulation Number: MBH
Classification Product Code: 11/13/2012
Date Received: 05/03/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: TRIATHLON TRITANIUM TIBIAL BASEPLATE
Manufacturer: AUDREY WITKO
Device Classification Name: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Regulation Number: MBH
Classification Product Code: 11/13/2012
Date Received: 05/03/2013
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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