RAY TFC DEVICE WITH INSTRUMENTATION (20MM)

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Premarket Approval P950019 S003

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 addition of 20mm cages and modified labeling.

DeviceRAY TFC DEVICE WITH INSTRUMENTATION (20MM)
Classification NameIntervertebral Fusion Device With Bone Graft, Lumbar
Generic NameIntervertebral Fusion Device With Bone Graft, Lumbar
ApplicantSTRYKER SPINE
Date Received1998-05-15
Decision Date1998-06-17
PMAP950019
SupplementS003
Product CodeMAX
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address STRYKER SPINE 2 Pearl Court allendale, NJ 07401

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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