|Trade Name||INTER FIX THREADED FUSION DEVICE, INTER FIX RP THREADED FUSION DEVICE AND LT-CAGE LUMBAR TAPERED FUSION DEVICE|
|Classification Name||intervertebral fusion device with bone graft, lumbar|
|Generic Name||intervertebral fusion device with bone graft, lumbar|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| location change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| 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 sterigenics, westerville, ohio and an additional testing facility located at namsa, northwood, ohio.