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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 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 NameRAY TFC UNITE PRODUCT LINE
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameinterbody fusion device
Regulation Number888.3080
ApplicantHOWMEDICA OSTEONICS CORP.
PMA NumberP950019
Supplement NumberS013
Date Received02/13/2003
Decision Date07/15/2003
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for new manufacturing facilities for the ray tfc unite product line. The facilities are located at centerpulse spine-tech, minneapolis, minnesota and biotest laboratories, inc. , minneapolis, minnesota.
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