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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 NameINTER FIX THREADED FUSION DEVICE, INTER FIX RP THREADED FUSION DEVICE AND LT-CAGE LUMBAR TAPERED FUSION DEVICE
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameintervertebral body fusion device
Regulation Number888.3080
ApplicantMEDTRONIC SOFAMOR DANEK USA, INC.
PMA NumberP970015
Supplement NumberS021
Date Received10/25/2002
Decision Date06/24/2003
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: packager
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an additional manufacturing facility to perform packaging for terminal sterilization. The facility is located at medtronic sofamor danek, warsaw, indiana. Also, approval for an additional sterilization facility located at iba steri genics, westerville, ohio and an additional testing facility located at namsa, northwood, ohio.
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