| Primary Device ID | M719GLP1560 |
| NIH Device Record Key | 0b3220aa-6d9e-4e3d-b23d-7b4c1ec1c4b2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lumbar Plate |
| Version Model Number | 1 |
| Catalog Number | GLP156 |
| Company DUNS | 017921066 |
| Company Name | Genesys Orthopedics Systems LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 5123817070 |
| info@genesysspine.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M719GLP1560 [Primary] |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M719GLP1560]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-13 |
| Device Publish Date | 2020-01-03 |
| M719GLPV60540 | 54mm Lumbar Plate Variable Rescue Screw |
| M719GLPV60500 | 50mm Lumbar Plate Variable Rescue Screw |
| M719GLPV60460 | 46mm Lumbar Plate Variable Rescue Screw |
| M719GLPV60420 | 42mm Lumbar Plate Variable Rescue Screw |
| M719GLPV60380 | 38mm Lumbar Plate Variable Rescue Screw |
| M719GLPV60340 | 34mm Lumbar Plate Variable Rescue Screw |
| M719GLPV60300 | 30mm Lumbar Plate Variable Rescue Screw |
| M719GLPV60260 | 26mm Lumbar Plate Variable Rescue Screw |
| M719GLPV60220 | 22mm Lumbar Plate Variable Rescue Screw |
| M719GLPV60180 | 18mm Lumbar Plate Variable Rescue Screw |
| M719GLPV55540 | 5.5mm x 54mm Lumbar Plate Variable Screw |
| M719GLPV55500 | 5.5mm x 50mm Lumbar Plate Variable Screw |
| M719GLPV55460 | 5.5mm x 46mm Lumbar Plate Variable Screw |
| M719GLPV55420 | 5.5mm x 42mm Lumbar Plate Variable Screw |
| M719GLPV55380 | 5.5mm x 30mm Lumbar Plate Variable Screw |
| M719GLPV55340 | 5.5mm x 34mm Lumbar Plate Variable Screw |
| M719GLPV55300 | 5.5mm x 30mm Lumbar Plate Variable Screw |
| M719GLPV55260 | 5.5mm x 26mm Lumbar Plate Variable Screw |
| M719GLPV55220 | 5.5mm x 22mm Lumbar Plate Variable Screw |
| M719GLPV55180 | 5.5mm x 18mm Lumbar Plate Variable Screw |
| M719GLPF60540 | 54mm Lumbar Plate Fixed Rescue Screw |
| M719GLPF60500 | 50mm Lumbar Plate Fixed Rescue Screw |
| M719GLPF60460 | 46mm Lumbar Plate Fixed Rescue Screw |
| M719GLPF60420 | 42mm Lumbar Plate Fixed Rescue Screw |
| M719GLPF60380 | 38mm Lumbar Plate Fixed Rescue Screw |
| M719GLPF60340 | 34mm Lumbar Plate Fixed Rescue Screw |
| M719GLPF60300 | 30mm Lumbar Plate Fixed Screw |
| M719GLPF60260 | 26mm Lumbar Plate Fixed Rescue Screw |
| M719GLPF60220 | 22mm Lumbar Plate Fixed Rescue Screw |
| M719GLPF60180 | 18mm Lumbar Plate Fixed Rescue Screw |
| M719GLPF55540 | 5.5mm x 54mm Lumbar Plate Fixed Screw |
| M719GLPF55500 | 5.5mm x 50mm Lumbar Plate Fixed Screw |
| M719GLPF55460 | 5.5mm x 46mm Lumbar Plate Fixed Screw |
| M719GLPF55420 | 5.5mm x 42mm Lumbar Plate Fixed Screw |
| M719GLPF55380 | 5.5mm x 38mm Lumbar Plate Fixed Screw |
| M719GLPF55340 | 5.5mm x 34mm Lumbar Plate Fixed Screw |
| M719GLPF55300 | 5.5mm x 30mm Lumbar Plate Fixed Screw |
| M719GLPF55260 | 5.5mm x 26mm Lumbar Plate Fixed Screw |
| M719GLPF55220 | 5.5mm x 22mm Lumbar Plate Fixed Screw |
| M719GLPF55180 | 5.5mm x 18mm Lumbar Plate Fixed Screw |
| M719GLP2020 | Lumbar Plate Straight Removal Sleeve |
| M719GLP2010 | Lumbar Plate Straight Screw Removal Tool |
| M719GLP1120 | Lumbar Plate Inserter |
| M719GLP1000 | Lumbar Plate-ALIF Inserter |
| M719GLPB400 | 40mm Berm Sacral Plate |
| M719GLPB370 | 37mm Berm Sacral Plate |
| M719GLPB340 | 34mm Berm Sacral Plate |
| M719GLPB310 | 31mm Berm Sacral Plate |
| M719GLPB280 | 28mm Berm Sacral Plate |
| M719GLPB250 | 25mm Berm Sacral Plate |