PMA P970015S021

Device: INTER FIX THREADED FUSION DEVICE, INTER FIX RP THREADED FUSION DEVICE AND LT-CAGE LUMBAR TAPERED FUSION DEVICE
Applicant: Sofamor Danek
PMA number: P970015
Supplement: S021
Product code: MAX
Decision date: 2003-06-24
Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
Generic name: Intervertebral fusion device with bone graft, lumbar
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.

Current openFDA PMA Record#

Device: INTER FIX THREADED FUSION DEVICE, INTER FIX RP THREADED FUSION DEVICE AND LT-CAGE LUMBAR TAPERED FUSION DEVICE
Applicant: Sofamor Danek
PMA number: P970015
Supplement: S021
Product code: MAX
Generic name: Intervertebral fusion device with bone graft, lumbar
Decision date: 2003-06-24
Decision code: APPR
Date received: 2002-10-25
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
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.