PMA P220002S007

Device: TOPS™ System
Applicant: Premia Spine, Ltd.
PMA number: P220002
Supplement: S007
Product code: QWK
Decision date: 2025-03-21
Classification: Orthopedic
Generic name: Prosthesis, posterior spinal elements
Approval order statement: addition of another subcontractor for the manufacturing of TOPS™ Motion Implant’s titanium components - Triangle Manufacturing Co., Inc., to enhance the manufacturing process

Current openFDA PMA Record#

Device: TOPS™ System
Applicant: Premia Spine, Ltd.
PMA number: P220002
Supplement: S007
Product code: QWK
Generic name: Prosthesis, posterior spinal elements
Decision date: 2025-03-21
Decision code: OK30
Date received: 2025-02-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: addition of another subcontractor for the manufacturing of TOPS™ Motion Implant’s titanium components - Triangle Manufacturing Co., Inc., to enhance the manufacturing process