PMA P220002S010

Device: TOPS™ System
Applicant: Premia Spine, Ltd.
PMA number: P220002
Supplement: S010
Product code: QWK
Decision date: 2025-10-29
Classification: Orthopedic
Generic name: Prosthesis, posterior spinal elements
Approval order statement: introduction of a new plug sorting jig, adjustment to the plug cutting and insertion machine, and minor dimensional changes to the plug and top plate components to and improve sealing performance at the Premia Spine Ltd, Ramat Poleg, Netanya, Isreal and TAV Medical Ltd, Israel facilities

Current openFDA PMA Record#

Device: TOPS™ System
Applicant: Premia Spine, Ltd.
PMA number: P220002
Supplement: S010
Product code: QWK
Generic name: Prosthesis, posterior spinal elements
Decision date: 2025-10-29
Decision code: OK30
Date received: 2025-09-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: introduction of a new plug sorting jig, adjustment to the plug cutting and insertion machine, and minor dimensional changes to the plug and top plate components to and improve sealing performance at the Premia Spine Ltd, Ramat Poleg, Netanya, Isreal and TAV Medical Ltd, Israel facilities