LUMBAR I/F CAGE SYSTEM

Spinal Pedicle Screw, Fixation, Appliance System

FDA Premarket Approval P960025 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

Approval for the use of the monarch spinal system to be used with the lumbar i/f cage system.

DeviceLUMBAR I/F CAGE SYSTEM
Classification NameSpinal Pedicle Screw, Fixation, Appliance System
Generic NameSpinal Pedicle Screw, Fixation, Appliance System
ApplicantDEPUY SPINE,INC
Date Received2001-12-26
Decision Date2002-02-04
PMAP960025
SupplementS009
Product CodeMCV
Advisory CommitteeOrthopedic
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address DEPUY SPINE,INC 325 Paramont Drive raynham, MA 02767

Supplemental Filings

Supplement NumberDateSupplement Type
P960025Original Filing
S011 2003-08-04 Normal 180 Day Track
S010 2003-02-24 Normal 180 Day Track
S009 2001-12-26 Real-time Process
S008 2001-09-04 Normal 180 Day Track
S007 2001-05-17 Normal 180 Day Track
S006 2001-03-27 Normal 180 Day Track
S005 2000-06-06 Normal 180 Day Track
S004 2000-04-06 Real-time Process
S003 2000-03-23 Real-time Process
S002 2000-03-06 Normal 180 Day Track
S001 1999-06-07 Normal 180 Day Track No User Fee

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