PMA P170036S016
- Device
- M6-C Artificial Cervical Disc
- Applicant
- Spinal Kinetics, LLC
- PMA number
- P170036
- Supplement
- S016
- Product code
- MJO
- Decision date
- 2024-08-19
- Classification
- Orthopedic
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- approval of use of the Keyence Laser Microscope/Profilometer to measure surface finishes on metal endplates and weld band
Current openFDA PMA Record#
- Device
- M6-C Artificial Cervical Disc
- Applicant
- Spinal Kinetics, LLC
- PMA number
- P170036
- Supplement
- S016
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2024-08-19
- Decision code
- OK30
- Date received
- 2024-07-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval of use of the Keyence Laser Microscope/Profilometer to measure surface finishes on metal endplates and weld band