LT-CAGE LUMBAR TAPERED FUSION DEVICE (TI AND PEEK)

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Premarket Approval P970015 S030

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 inclusion of additional fusion cage component designs. Specifically, these design changes involved the incorporation of a rounded profile to the closed end of the tapered cage components. The modified tapered cage components can only be implanted via an anterior open surgical approach.

• Device: LT-CAGE LUMBAR TAPERED FUSION DEVICE (TI AND PEEK)
• Classification Name: Intervertebral Fusion Device With Bone Graft, Lumbar
• Generic Name: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: SOFAMOR DANEK
• Date Received: 2004-11-15
• Decision Date: 2005-02-04
• PMA: P970015
• Supplement: S030
• Product Code: MAX
• Advisory Committee: Orthopedic
• Supplement Type: Real-time Process
• Supplement Reason: Change Design/components/specifications/material
• 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