PMA P040006S004

Device: IN MOTION ARTIFICIAL DISC
Applicant: Depuy Spine, Inc.
PMA number: P040006
Supplement: S004
Product code: MJO
Decision date: 2007-09-05
Generic name: Prosthesis, intervertebral disc
Approval order statement: APPROVAL FOR: 1) ADDITIONAL ENDPLATES WITH LARGER FOOTPRINT, LATERAL PLACEMENT OF FIXATION TEETH, AND 1 MM OFFSET ARTICULATING SURFACE; 2) ADDITIONAL CORES WITH MODIFIED OUTER RIM; 3) MODIFIED SURGICAL INSTRUMENTS TO ACCOMMODATE MODIFIED DEVICE COMPONENTS; AND 4) MODIFIED SURGICAL TECHNIQUE.

Current openFDA PMA Record#

Device: IN MOTION ARTIFICIAL DISC
Applicant: Depuy Spine, Inc.
PMA number: P040006
Supplement: S004
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2007-09-05
Decision code: APPR
Date received: 2007-03-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR: 1) ADDITIONAL ENDPLATES WITH LARGER FOOTPRINT, LATERAL PLACEMENT OF FIXATION TEETH, AND 1 MM OFFSET ARTICULATING SURFACE; 2) ADDITIONAL CORES WITH MODIFIED OUTER RIM; 3) MODIFIED SURGICAL INSTRUMENTS TO ACCOMMODATE MODIFIED DEVICE COMPONENTS; AND 4) MODIFIED SURGICAL TECHNIQUE.