|
Device | SPF PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M) |
Generic Name | Stimulator, invasive bone growth |
Applicant | EBI, LLC 1 Gatehall Drive Suite 303 Parsippany, NJ 07054 |
PMA Number | P850035 |
Supplement Number | S033 |
Date Received | 07/22/2008 |
Decision Date | 09/18/2008 |
Product Code |
LOE |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE TRADE NAME WHICH WAS PREVIOUSLY APPROVED AS: SPF-PLUS (60/W) AND SPF- PLUS (60/M). THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME SPF PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M) AND IS INDICATED AS A SPINAL FUSING ADJUNCT TO INCREASE THE PROBABILITY OF FUSION SUCCESS IN 1 OR 2 LEVELS. |