PMA P220002S005

Device: TOPS System
Applicant: Premia Spine, Ltd.
PMA number: P220002
Supplement: S005
Product code: QWK
Decision date: 2025-01-17
Classification: Orthopedic
Generic name: Prosthesis, posterior spinal elements
Approval order statement: Change to introduce three (3) semi-automated machines as alternatives to the current manual process for certain TOPS™ assembly steps at the established manufacturing facility in Netanya, Israel for enhanced reproducibility / reliability

Current openFDA PMA Record#

Device: TOPS System
Applicant: Premia Spine, Ltd.
PMA number: P220002
Supplement: S005
Product code: QWK
Generic name: Prosthesis, posterior spinal elements
Decision date: 2025-01-17
Decision code: OK30
Date received: 2024-12-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to introduce three (3) semi-automated machines as alternatives to the current manual process for certain TOPS™ assembly steps at the established manufacturing facility in Netanya, Israel for enhanced reproducibility / reliability