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FDA 510(k), K133811, RESTORIS POROUS PARTIAL KNEE SYSTEM
FDA 510(k), K133811, RESTORIS POROUS PARTIAL KNEE SYSTEM
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510(K) Number: K133811
Device Name: RESTORIS POROUS PARTIAL KNEE SYSTEM
Manufacturer: TERRY POWELL
Device Classification Name: Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
Regulation Number: NJD
Classification Product Code: 12/16/2013
Date Received: 07/08/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: RESTORIS POROUS PARTIAL KNEE SYSTEM
Manufacturer: TERRY POWELL
Device Classification Name: Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
Regulation Number: NJD
Classification Product Code: 12/16/2013
Date Received: 07/08/2014
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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