PMA P040006S002

Device: CHARITE ARTIFICIAL DISC
Applicant: Depuy Spine, Inc.
PMA number: P040006
Supplement: S002
Product code: MJO
Decision date: 2006-03-29
Generic name: Prosthesis, intervertebral disc
Approval order statement: APPROVAL FOR 1) NEW ENDPLATES COATED WITH VACUUM PLASMA-SPRAYED PURE TITANIUM AND CALCIUM PHOSPHATE; 2) THREE NEW INTERMEDIATE ENDPLATE SIZES UTILIZING THIS SAME COATING; AND 3) VARIOUS SURGICAL INSTRUMENTS TO ACCOMMODATE THE PROPOSED NEW ENDPLATES.

Current openFDA PMA Record#

Device: CHARITE ARTIFICIAL DISC
Applicant: Depuy Spine, Inc.
PMA number: P040006
Supplement: S002
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2006-03-29
Decision code: APPR
Date received: 2005-02-22
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR 1) NEW ENDPLATES COATED WITH VACUUM PLASMA-SPRAYED PURE TITANIUM AND CALCIUM PHOSPHATE; 2) THREE NEW INTERMEDIATE ENDPLATE SIZES UTILIZING THIS SAME COATING; AND 3) VARIOUS SURGICAL INSTRUMENTS TO ACCOMMODATE THE PROPOSED NEW ENDPLATES.