PMA P100012S005
- Device
- NUVASIVE PCM CERVICAL DISC SYSTEM
- Applicant
- Nuvasive, Inc.
- PMA number
- P100012
- Supplement
- S005
- Product code
- MJO
- Decision date
- 2014-03-07
- Classification
- Prosthesis, Intervertebral Disc
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- APPROVAL FOR DESIGN CHANGES TO THE PCM INSERTER AND REDEFINING AND TIGHTENING IMPLANT TOLERANCES.
Current openFDA PMA Record#
- Device
- NUVASIVE PCM CERVICAL DISC SYSTEM
- Applicant
- Nuvasive, Inc.
- PMA number
- P100012
- Supplement
- S005
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2014-03-07
- Decision code
- APPR
- Date received
- 2013-12-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR DESIGN CHANGES TO THE PCM INSERTER AND REDEFINING AND TIGHTENING IMPLANT TOLERANCES.