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. |
|
Device | SPF PLUS 60/W AND SPF-PLUS 60/M |
Generic Name | Stimulator, invasive bone growth |
Applicant | EBI, LLC 1 Gatehall Drive Suite 303 Parsippany, NJ 07054 |
PMA Number | P850035 |
Supplement Number | S031 |
Date Received | 02/23/2007 |
Decision Date | 06/21/2007 |
Product Code |
LOE |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR DEVICE MODIFICATIONS TO INCORPORATE IDENTICAL BATTERY CHEMISTRY AND IMPLANT TESTER CONFIGURATION AS APPROVED IN THE SPF-XL IIB DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPF-PLUS 60/W AND SPF-PLUS 60/M AND IS INDICATED AS A SPINAL FUSION ADJUNCT TO INCREASE THE PROBABILITY OF FUSION SUCCESS IN 1 OR 2 LEVELS. |
|
|