FDA 510(k), K102549, THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY
FDA 510(k), K102549, THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY
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510(K) Number: K102549
Device Name: THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY
Manufacturer: SUSAN WALTON
Device Classification Name: Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Regulation Number: LZJ
Classification Product Code: 09/07/2010
Date Received: 12/21/2010
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY
Manufacturer: SUSAN WALTON
Device Classification Name: Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Regulation Number: LZJ
Classification Product Code: 09/07/2010
Date Received: 12/21/2010
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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