Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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.
 
DeviceLUMBAR I/F CAGE WITH VSP SPINAL SYSTEM
Generic NameSPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM
ApplicantDepuy Spine, Inc.
325 Paramont Dr.
Raynham, MA 02767
PMA NumberP960025
Supplement NumberS001
Date Received06/07/1999
Decision Date07/16/1999
Reclassified Date07/12/2007
Product Code MCV 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the packaging and distribution facility located at DePuy AcroMed, Inc., 325 Paramount Drive, Rayhnam, Massachusetts 02767.
-
-