PMA P850007S014
- Device
- SPINAL-STIM(R)
- Applicant
- Orthofix, Inc.
- PMA number
- P850007
- Supplement
- S014
- Product code
- LOF
- Decision date
- 1996-09-19
- Classification
- Stimulator, Bone Growth, Non-invasive
- Generic name
- Stimulator, bone growth, non-invasive
- Approval order statement
- COMPANY PROVIDED FINAL DRAFT LABELING MODIFIED TO REFLECT THE LONG-TERM SUCCESS RATES FOR THE DEVICE. TRADE NAME:SPINAL-STIM
Current openFDA PMA Record#
- Device
- SPINAL-STIM(R)
- Applicant
- Orthofix, Inc.
- PMA number
- P850007
- Supplement
- S014
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 1996-09-19
- Decision code
- APPR
- Date received
- 1994-03-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- COMPANY PROVIDED FINAL DRAFT LABELING MODIFIED TO REFLECT THE LONG-TERM SUCCESS RATES FOR THE DEVICE. TRADE NAME:SPINAL-STIM