RAY TFC DEVICE AND RAY TFC UNITE DEVICE

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Premarket Approval P950019 S009

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

Modified indications for use for the ray tfc and unite threaded fusion cage with instrumentation. These devices are indicated for use with autogenous bone grafts in patients with degenerative disc disease (ddd) at one or two levels for l2 to s1.

DeviceRAY TFC DEVICE AND RAY TFC UNITE DEVICE
Classification NameIntervertebral Fusion Device With Bone Graft, Lumbar
Generic NameIntervertebral Fusion Device With Bone Graft, Lumbar
ApplicantSTRYKER SPINE
Date Received1999-05-03
Decision Date2000-03-02
PMAP950019
SupplementS009
Product CodeMAX
Docket Number00M-1212
Advisory CommitteeOrthopedic
Supplement TypePanel Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address STRYKER SPINE 2 Pearl Court allendale, NJ 07401
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P950019Original Filing
S016 2003-09-26 Special (immediate Track)
S015 2003-07-28 Special (immediate Track)
S014 2003-02-13 Normal 180 Day Track No User Fee
S013 2003-02-13 Normal 180 Day Track No User Fee
S012 2002-02-11 Real-time Process
S011 2000-03-21 30-day Notice
S010 1999-09-27 Normal 180 Day Track
S009 1999-05-03 Panel Track
S008 1999-04-20 Normal 180 Day Track
S007 1999-02-18 Real-time Process
S006 1999-01-20 Real-time Process
S005 1998-10-20 Real-time Process
S004 1998-08-18 Real-time Process
S003 1998-05-15 Normal 180 Day Track
S002 1998-05-08 Real-time Process
S001 1997-03-18 Normal 180 Day Track

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