PMA P220002S004
- Device
- TOPS™ System
- Applicant
- Premia Spine, Ltd.
- PMA number
- P220002
- Supplement
- S004
- Product code
- QWK
- Decision date
- 2024-06-20
- Classification
- Orthopedic
- Generic name
- Prosthesis, posterior spinal elements
- Approval order statement
- Approval for the use of additional pedicle screw components (slender tulip cannulated-tapered and non-cannulated screws) with the TOPS™ System.
Current openFDA PMA Record#
- Device
- TOPS™ System
- Applicant
- Premia Spine, Ltd.
- PMA number
- P220002
- Supplement
- S004
- Product code
- QWK
- Generic name
- Prosthesis, posterior spinal elements
- Decision date
- 2024-06-20
- Decision code
- APPR
- Date received
- 2023-09-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the use of additional pedicle screw components (slender tulip cannulated-tapered and non-cannulated screws) with the TOPS™ System.