PMA P850007S031

Device: SPINAL-STIM SPINAL FUSION SYSTEM
Applicant: Orthofix, Inc.
PMA number: P850007
Supplement: S031
Product code: LOF
Decision date: 2011-03-11
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
Approval order 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 THE LAST SURGERY.

Current openFDA PMA Record#

Device: SPINAL-STIM SPINAL FUSION SYSTEM
Applicant: Orthofix, Inc.
PMA number: P850007
Supplement: S031
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 2011-03-11
Decision code: APPR
Date received: 2011-01-19
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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 THE LAST SURGERY.