zLOCK Lumbar Facet Fixation System
Zygofix , Ltd.
ZygoFix
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3031232974 | 3031232974 | ZygoFix | 1 | N | 2026-01-01 | 17 Tchelet Street Misgav Industrial Park D.N. Misgav Northern IL 2017400 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 328856 | 1135108120 | K242650 | zLOCK Lumbar Facet Fixation System | MRW | 2024-09-20 |
| 328856 | 1723596717 | K240085 | zLOCK Lumbar Facet Fixation System | MRW | 2024-04-18 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MRW | 2 | 2024-09-20 |
PMN#
zLOCK Lumbar Facet Fixation System
Zygofix , Ltd.
GUDID#
zLOCK 1.5mm - The subjected Spacer of 1.5 mm is part of the zLOCK Lumbar Facet Fixation System. The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components:1) a Facet Screw with a washer and2) a Modular spacer.The system including a dedicated tool set.
2024-09-05
zLOCK 2.0mm - The subjected Spacer of 2.0 mm is part of the zLOCK Lumbar Facet Fixation System. The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components:1) a Facet Screw with a washer and2) a Modular spacer.The system including a dedicated tool set.
2024-09-05
zLOCK 2.5mm - The subjected Spacer of 2.5 mm is part of the zLOCK Lumbar Facet Fixation System. The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components:1) a Facet Screw with a washer and2) a Modular spacer.The system including a dedicated tool set.
2024-09-05
zLOCK 3.0mm - The subjected Spacer of 3.0 mm is part of the zLOCK Lumbar Facet Fixation System. The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components:1) a Facet Screw with a washer and2) a Modular spacer.The system including a dedicated tool set.
2024-09-05
zLOCK 3.5mm - The subjected Spacer of 3.5 mm is part of the zLOCK Lumbar Facet Fixation System. The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components:1) a Facet Screw with a washer and2) a Modular spacer.The system including a dedicated tool set.
2024-09-05
zLOCK 4.0mm - The subjected Spacer of 4.0 mm is part of the zLOCK Lumbar Facet Fixation System. The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components:1) a Facet Screw with a washer and2) a Modular spacer.The system including a dedicated tool set.
2024-09-05
zLOCK tools Tray #1 - The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components:1) a Facet Screw with a washer and2) a Modular spacer.The system including a dedicated tool set, contained in dedicated trays that are marked with UDI.
2024-10-20
zLOCK tools Tray #2 - The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components:1) a Facet Screw with a washer and2) a Modular spacer.The system including a dedicated tool set, contained in dedicated trays that are marked with UDI.
2024-10-20
zLOCK tools Tray #3 - The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components:1) a Facet Screw with a washer and2) a Modular spacer.The system including a dedicated tool set, contained in dedicated trays that are marked with UDI.
2024-10-20
zLOCK tools Trays #1+ #2 - The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components:1) a Facet Screw with a washer and2) a Modular spacer.The system including a dedicated tool set, contained in dedicated trays that are marked with UDI.
2024-10-20
zLOCK tools Trays #1+ #3 - The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components:1) a Facet Screw with a washer and2) a Modular spacer.The system including a dedicated tool set, contained in dedicated trays that are marked with UDI.
2024-10-20
Facet Screw - The subjected screw is part of the zLOCK Lumbar Facet Fixation System. The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components:1) a Facet Screw with a washer and2) a Modular spacer.The system including a dedicated tool set.
2024-10-20
Facet screw - The subjected screw is part of the zLOCK Lumbar Facet Fixation System. The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components:1) a Facet Screw with a washer and2) a Modular spacer.The system including a dedicated tool set.
2024-09-05