INTER FIX TM THREADED FUSION DEVICE

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Premarket Approval P970015 S031

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 the post approval study. The device remains indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (ddd) at one level from l2-s1. Ddd is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These ddd patients may also have up to grade i spondylolisthesis or retrolisthesis at the involved level. Inter fix implants and inter fix rp implants are to be used with autogenous bone graft and implanted via an open anterior approach.

• Device: INTER FIX TM THREADED 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: 2005-01-28
• Decision Date: 2005-07-27
• PMA: P970015
• Supplement: S031
• Product Code: MAX
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Other Report
• 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