PMA P220002S006

Device: TOPS™ System
Applicant: Premia Spine, Ltd.
PMA number: P220002
Supplement: S006
Product code: QWK
Decision date: 2025-03-25
Classification: Orthopedic
Generic name: Prosthesis, posterior spinal elements
Approval order statement: Approval for the use of additional pedicle screw components (CD Horizon Solera Ø6.5-7.5mm non-cannulated, multi-axial pedicle screws with lengths from 25-60mm manufactured by Medtronic Sofamor Danek USA, Inc.) with the TOPS™ System

Current openFDA PMA Record#

Device: TOPS™ System
Applicant: Premia Spine, Ltd.
PMA number: P220002
Supplement: S006
Product code: QWK
Generic name: Prosthesis, posterior spinal elements
Decision date: 2025-03-25
Decision code: APPR
Date received: 2024-12-26
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 (CD Horizon Solera Ø6.5-7.5mm non-cannulated, multi-axial pedicle screws with lengths from 25-60mm manufactured by Medtronic Sofamor Danek USA, Inc.) with the TOPS™ System