INTER FIX THREADED FUSION DEVICE, INTER FIX RP THREADED FUSION DEVICE AND LT-CAGE LUMBAR TAPERED FUSION DEVICE

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Premarket Approval P970015 S021

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.

Pre-market Approval Supplement Details

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.

• Device: 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
• Applicant: SOFAMOR DANEK
• Date Received: 2002-10-25
• Decision Date: 2003-06-24
• PMA: P970015
• Supplement: S021
• Product Code: MAX
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: SOFAMOR DANEK 1800 Pyramid Place memphis, TN 38132

Supplemental Filings

Supplement Number	Date	Supplement Type
P970015		Original Filing
S031	2005-01-28	Normal 180 Day Track No User Fee
S030	2004-11-15	Real-time Process
S029	2004-09-22	Real-time Process
S028	2004-07-01	30-day Notice
S027	2004-03-19	Special (immediate Track)
S026	2004-03-19	Special (immediate Track)
S025	2003-08-25	Normal 180 Day Track No User Fee
S024
S023
S022	2002-10-30	Normal 180 Day Track
S021	2002-10-25	Normal 180 Day Track No User Fee
S020	2002-04-04	Normal 180 Day Track
S019	2001-04-09	Normal 180 Day Track
S018
S017	2000-09-28	Normal 180 Day Track
S016
S015
S014	2000-05-23	Normal 180 Day Track
S013	2000-02-02	Normal 180 Day Track
S012
S011	1999-12-21	Normal 180 Day Track
S010	1999-11-24	Normal 180 Day Track
S009	1999-10-07	Normal 180 Day Track
S008	1999-10-06	Normal 180 Day Track
S007
S006
S005	1999-08-02	Real-time Process
S004
S003	1998-12-04	Normal 180 Day Track
S002	1998-09-09	Normal 180 Day Track
S001	1998-06-15	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
00673978955827	P970015	008
00673978955810	P970015	008
00673978957593	P970015	009
00673978957586	P970015	009
00613994618733	P970015	022