| Primary Device ID | M719GLP15420 |
| NIH Device Record Key | 9e3ed59a-1a95-4504-bd76-367cb352f739 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lumbar Plate System |
| Version Model Number | 1 |
| Catalog Number | GLP154-2 |
| 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 | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M719GLP15420 [Primary] |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M719GLP15420]
Moist Heat or Steam Sterilization
[M719GLP15420]
Moist Heat or Steam Sterilization
[M719GLP15420]
Moist Heat or Steam Sterilization
[M719GLP15420]
Moist Heat or Steam Sterilization
[M719GLP15420]
Moist Heat or Steam Sterilization
[M719GLP15420]
Moist Heat or Steam Sterilization
[M719GLP15420]
Moist Heat or Steam Sterilization
[M719GLP15420]
Moist Heat or Steam Sterilization
[M719GLP15420]
Moist Heat or Steam Sterilization
[M719GLP15420]
Moist Heat or Steam Sterilization
[M719GLP15420]
Moist Heat or Steam Sterilization
[M719GLP15420]
Moist Heat or Steam Sterilization
[M719GLP15420]
Moist Heat or Steam Sterilization
[M719GLP15420]
Moist Heat or Steam Sterilization
[M719GLP15420]
Moist Heat or Steam Sterilization
[M719GLP15420]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-31 |
| Device Publish Date | 2023-07-21 |
| M719GLP100000250 | 25mm Lumbar Plate |
| M719GLP100000230 | 23mm Lumbar Plate |
| M719GLP100000210 | 21mm Lumbar Plate |
| M719GLP100000190 | 19mm Lumbar Plate |
| M719GLP100000170 | 17mm Lumbar Plate |
| M719GLP100000150 | 15mm Lumbar Plate |
| M719GLPV55320 | 5.5mm x 32mm Lumbar Plate Variable Screw |
| M719GLPV55280 | 5.5mm x 28mm Lumbar Plate Variable Screw |
| M719GLPV55240 | 5.5mm x 24mm Lumbar Plate Variable Screw |
| M719GLPV55200 | 5.5mm x 20mm Lumbar Plate Variable Screw |
| M719GLP1630 | Lumbar Plate LP Basic Screwdriver |
| M719GLP1620 | Lumbar Plate Angled Awl Guide |
| M719GLP1610 | Lumbar Plate Jointed Driver |
| M719GLP1600 | Lumbar Plate Jointed Awl |
| M719GLP1590 | Lumbar Plate Helios Driver - Assembly |
| M719GLP15420 | Lumbar Plate Shielded Awl, No Spring |
| M719GLP10155320 | 5.5mm x 32mm Lumbar Screw |
| M719GLP10155280 | 5.5mm x 28mm Lumbar Screw |
| M719GLP10155240 | 5.5mm x 24mm Lumbar Screw |
| M719GLP10155210 | 5.5 x 21mm Lumbar Screw |
| M719GLP10101320 | 32mm Lumbar Plate Drill |
| M719GLP10101280 | 28mm Lumbar Plate Drill |
| M719GLP10101240 | 24mm Lumbar Plate Drill |