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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 SPINE SYSTEM
Classification Namespinal pedicle screw, fixation, appliance system
Generic Namespinal pedicle screw, fixation, appliance system
Applicant
DEPUY SPINE,INC
325 paramont drive
raynham, MA 02767
PMA NumberP960025
Supplement NumberS003
Date Received03/23/2000
Decision Date04/10/2000
Product Code
MCV[ Registered Establishments with MCV ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of additional sizes for the Lumbar I/F Cage.
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