PMA P220002
- Device
- TOPS™ System
- Applicant
- Premia Spine, Ltd.
- Product code
- QWK
- Decision date
- 2026-09-09
- Generic name
- Prosthesis, posterior spinal elements
- Approval order statement
- addition of an additional subcontractor for the manufacturing of pedicle screw components to be used with the TOPS™ implant - Triangle Manufacturing Co., Inc.
Current openFDA PMA Record#
- Device
- TOPS™ System
- Applicant
- Premia Spine, Ltd.
- PMA number
- P220002
- Supplement
- S011
- Product code
- QWK
- Generic name
- Prosthesis, posterior spinal elements
- Decision date
- 2026-09-09
- Decision code
- OK30
- Date received
- 2026-08-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of an additional subcontractor for the manufacturing of pedicle screw components to be used with the TOPS™ implant - Triangle Manufacturing Co., Inc.