PHYSIO-STIM & SPINAL-STIM
FDA premarket approval P850007/S028 · decided 2009-07-10
Approval details
- PMA number
- P850007
- Supplement
- S028
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PHYSIO-STIM & SPINAL-STIM
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 2009-05-07
- Decision date
- 2009-07-10
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- APPROVAL FOR THE RELOCATION AND CHANGE OF THE CHARGE MANAGEMENT CONTROLLER AND THE REPLACEMENT OF THE CHARGER UNIT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PHYSIO-STIM AND SPINAL-STIM. THE PHYSIO-SLIM IS INDICATED FOR THETREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VERTEBRAE AND ALLFLAT BONES, WHERE THE WIDTH OF THE NONUNION DEFECTS IS LESS THAN ONE-HALF THE WIDTH OF THE BONE TO BE TREATED. A NONUNION IS CONSIDERED LO BE ESTABLISHED WHEN THE
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