PMA P070001S007

Device
PRODISC-C TOTAL DISC REPLACEMENT
Applicant
Centinel Spine, LLC
PMA number
P070001
Supplement
S007
Product code
MJO
Decision date
2010-07-02
Classification
Prosthesis, Intervertebral Disc
Generic name
Prosthesis, intervertebral disc
Approval order statement
MODIFIED FIXTURE USED FOR INSPECTION OF THE PRODISC-C ENDPLATES.

Current openFDA PMA Record#

Device
PRODISC-C TOTAL DISC REPLACEMENT
Applicant
Centinel Spine, LLC
PMA number
P070001
Supplement
S007
Product code
MJO
Generic name
Prosthesis, intervertebral disc
Decision date
2010-07-02
Decision code
OK30
Date received
2010-06-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
MODIFIED FIXTURE USED FOR INSPECTION OF THE PRODISC-C ENDPLATES.