• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameBAK/L INTERBODY FUSION SYSTEM
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Namelumbar interbody fusion instrumentation
Regulation Number888.3080
ApplicantSPINTECH, INC.
PMA NumberP950002
Supplement NumberS008
Date Received10/22/1999
Decision Date12/20/1999
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the additional sizes to the bak product line.
-
-