PMA P220002S002

Device: TOPS™ System
Applicant: Premia Spine, Ltd.
PMA number: P220002
Supplement: S002
Product code: QWK
Decision date: 2023-09-07
Classification: Orthopedic
Generic name: Prosthesis, posterior spinal elements
Approval order statement: Information provided by the firm to support the following changes: 1. The addition of two (2) semi-automated assembly machines (Boot to TOP Plate machine-EGEQ88244 and Core Assembly to TOP Plate-EGEQ88242), as alternative to the current manual process, for certain assembly steps of the TOPS; and 2) Flip the insertion orientation of the Polycarbonate Urethane (PcU) Plug prior to its insertion into the TOPS Top Plate.

Current openFDA PMA Record#

Device: TOPS™ System
Applicant: Premia Spine, Ltd.
PMA number: P220002
Supplement: S002
Product code: QWK
Generic name: Prosthesis, posterior spinal elements
Decision date: 2023-09-07
Decision code: OK30
Date received: 2023-08-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Information provided by the firm to support the following changes: 1. The addition of two (2) semi-automated assembly machines (Boot to TOP Plate machine-EGEQ88244 and Core Assembly to TOP Plate-EGEQ88242), as alternative to the current manual process, for certain assembly steps of the TOPS; and 2) Flip the insertion orientation of the Polycarbonate Urethane (PcU) Plug prior to its insertion into the TOPS Top Plate.