SPINAL-STIM SPINAL FUSION SYSTEM
FDA premarket approval P850007/S031 · decided 2011-03-11
Approval details
- PMA number
- P850007
- Supplement
- S031
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SPINAL-STIM SPINAL FUSION SYSTEM
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 2011-01-19
- Decision date
- 2011-03-11
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- APPROVAL FOR DESIGN MODIFICATIONS TO THE GARMENT COVERING, THE TREATMENT COILS, LIQUID CRYSTAL DISPLAY, CONTROL UNIT HOUSING PROFILE, ORIENTATION OF THE CONTROLS, SOFTWARE/ FIRMWARE, POWER SUPPLY CORD, AND LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPINAL-STIM AND IS INDICATED AS A SPINAL FUSION ADJUNCT TO INCREASE THE PROBABILITY OF FUSION SUCCESS AND AS A NON-OPERATIVE TREATMENT FOR SALVAGE OF FAILED SPINAL FUSION, WHERE A MINIMUM OF NINE MONTHS HAS ELAPSED SINCE
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.