PMA P170036S015
- Device
- M6-C Artificial Cervical Disc
- Applicant
- Spinal Kinetics, LLC
- PMA number
- P170036
- Supplement
- S015
- Product code
- MJO
- Decision date
- 2024-07-10
- Classification
- Orthopedic
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Approval for updated labeling to communicate storage temperature limitations on external packaging and instructions for use
Current openFDA PMA Record#
- Device
- M6-C Artificial Cervical Disc
- Applicant
- Spinal Kinetics, LLC
- PMA number
- P170036
- Supplement
- S015
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2024-07-10
- Decision code
- APPR
- Date received
- 2024-06-10
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for updated labeling to communicate storage temperature limitations on external packaging and instructions for use