Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | SPINAL-STIM SPINAL FUSION SYSTEM |
Generic Name | Stimulator, bone growth, non-invasive |
Applicant | Orthofix, Inc. 3451 Plano Parkway Lewisville, TX 75056 |
PMA Number | P850007 |
Supplement Number | S031 |
Date Received | 01/19/2011 |
Decision Date | 03/11/2011 |
Product Code |
LOF |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |
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