PMA P220002S009
- Device
- TOPS™ System
- Applicant
- Premia Spine, Ltd.
- PMA number
- P220002
- Supplement
- S009
- Product code
- QWK
- Decision date
- 2026-05-29
- Classification
- Orthopedic
- Generic name
- Prosthesis, posterior spinal elements
- Approval order statement
- Approval for the addition of a new inserter (TOPS™ 2 inserter) and implant design variant (TOPS™ 2) to be included in the TOPS™ System
Current openFDA PMA Record#
- Device
- TOPS™ System
- Applicant
- Premia Spine, Ltd.
- PMA number
- P220002
- Supplement
- S009
- Product code
- QWK
- Generic name
- Prosthesis, posterior spinal elements
- Decision date
- 2026-05-29
- Decision code
- APPR
- Date received
- 2025-08-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of a new inserter (TOPS™ 2 inserter) and implant design variant (TOPS™ 2) to be included in the TOPS™ System