PMA P220002S003

Device: TOPS™ System
Applicant: Premia Spine, Ltd.
PMA number: P220002
Supplement: S003
Product code: QWK
Decision date: 2023-10-27
Classification: Orthopedic
Generic name: Prosthesis, posterior spinal elements
Approval order statement: Change to introduce a semi-automated machine for the insertion of the Polycarbonate Urethane (PcU) Plug, adjustment to the Leak Detection Machine and change to the pedicle screw body surface blasting of the TOPS™ System.

Current openFDA PMA Record#

Device: TOPS™ System
Applicant: Premia Spine, Ltd.
PMA number: P220002
Supplement: S003
Product code: QWK
Generic name: Prosthesis, posterior spinal elements
Decision date: 2023-10-27
Decision code: OK30
Date received: 2023-09-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to introduce a semi-automated machine for the insertion of the Polycarbonate Urethane (PcU) Plug, adjustment to the Leak Detection Machine and change to the pedicle screw body surface blasting of the TOPS™ System.