PMA P050010S005
- Device
- PRODISC L TOTAL REPLACEMENT
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S005
- Product code
- MJO
- Decision date
- 2010-05-26
- Classification
- Prosthesis, Intervertebral Disc
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- NEW MAHR PERTHOMETER THAT USES A DIFFERENT SOFTWARE VERSION THAN THE EXISTING MAHR PERTHOMETER USED TO MEASURE SURFACE TOUGHNESS.
Current openFDA PMA Record#
- Device
- PRODISC L TOTAL REPLACEMENT
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S005
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2010-05-26
- Decision code
- OK30
- Date received
- 2010-04-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- NEW MAHR PERTHOMETER THAT USES A DIFFERENT SOFTWARE VERSION THAN THE EXISTING MAHR PERTHOMETER USED TO MEASURE SURFACE TOUGHNESS.