• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceSPF PLUS 60/W AND SPF-PLUS 60/M
Classification Namestimulator, invasive bone growth
Generic Namestimulator, invasive bone growth
Applicant
EBI, LLC
399 jefferson road
parsippany, NJ 07054
PMA NumberP850035
Supplement NumberS031
Date Received02/23/2007
Decision Date06/21/2007
Product Code
LOE[ Registered Establishments with LOE ]
Advisory Committee Orthopedic
Supplement Typereal-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.
-
-