TiLock G8811
GUDID M719G88110
Modular Tulip / Lock Screw Caddy
Genesys Orthopedics Systems LLC
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | M719G88110 |
| NIH Device Record Key | 9938495e-4d0e-411a-b674-406f322f5162 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TiLock |
| Version Model Number | 1 |
| Catalog Number | G8811 |
| 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 | true |
| 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 |
Customer Support Contacts
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com | |
| Phone | 512-381-7070 |
| info@genesysspine.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M719G88110 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K103671
FDA Product Code
| MNI | Orthosis, Spinal Pedicle Fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M719G88110]
Moist Heat or Steam Sterilization
[M719G88110]
Moist Heat or Steam Sterilization
[M719G88110]
Moist Heat or Steam Sterilization
[M719G88110]
Moist Heat or Steam Sterilization
[M719G88110]
Moist Heat or Steam Sterilization
[M719G88110]
Moist Heat or Steam Sterilization
[M719G88110]
Moist Heat or Steam Sterilization
[M719G88110]
Moist Heat or Steam Sterilization
[M719G88110]
Moist Heat or Steam Sterilization
[M719G88110]
Moist Heat or Steam Sterilization
[M719G88110]
Moist Heat or Steam Sterilization
[M719G88110]
Moist Heat or Steam Sterilization
[M719G88110]
Moist Heat or Steam Sterilization
[M719G88110]
Moist Heat or Steam Sterilization
[M719G88110]
Moist Heat or Steam Sterilization
[M719G88110]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-31 |
| Device Publish Date | 2023-07-21 |
On-Brand Devices [TiLock]
| M719GM581700 | 70mm Modular XT Tulip Assembly |
| M719GM5811000 | 100mm Modular XT Tulip Assembly |
| M719GM1320 | Modular Thread-On Tulip Inserter |
| M719GM1300 | Modular TTS Rod Inserter |
| M719GM1230 | Modular Tulip Insert and Tug Wand |
| M719GM1100 | Modular Tulip Popper |
| M719GM1020 | Modular Tulip Insertion Wand |
| M719GLC6130 | Luer-Lock Connector |
| M719GLC47620 | DMDSA Half Torque |
| M719GLC47610 | DMDSA Half Torque |
| M719GLC47220 | DMDSA Counter Torque |
| M719GLC47210 | DMDSA Counter Torque |
| M719GLC46820 | DMDSA Modular Counter Torque |
| M719GLC46810 | DMDSA Modular Counter Torque |
| M719GLC2120 | MIS Thread-In Driver |
| M719GL4240 | Quarter Connect Slide Hammer |
| M719GL304850 | Torque Limiter Handle - 85 in/lb |
| M719G88510 | Single Domino |
| M719GM8210 | Modular Solid Lock Screw |
| M719GM135SN0 | SN Modular Locking Screw Driver |
| M719GM135MS0 | MS Modular Locking Screw Driver |
| M719GM1350 | Modular Locking Screw Driver No Sleeve |
| M719GMSS50400 | 5.0mm x 40mm Modular Solid Single Thread Screw |
| M719GMSS50350 | 5.0mm x 35mm Modular Solid Single Thread Screw |
| M719GMSS50300 | 5.0mm x 30mm Modular Solid Single Thread Screw |
| M719GMSS50250 | 5.0mm x 25mm Modular Solid Single Thread Screw |
| M719GM1200 | Modular Drill Guide |
| M719GM1120 | Cortical Drill Guide |
| M719GM1250 | Modular Tip Reamer |
| M719G1501050 | Pre-Bent Rod |
| M719GL116TS0 | Targeting Awl Stylet |
| M719GL116TA0 | Duckbill Targeting Awl |
| M719GL11380 | 1/4" Connector Probe - Curved |
| M719GL11370 | 1/4" Connector Probe - Straight |
| M719GL11360 | 1/4" Connector Probe - Slim Duckbill |
| M719GL11350 | 1/4" Connector Probe - Duckbill |
| M719GL11340 | 1/4" Connector Probe - Curved Tapered Lenke |
| M719GL11330 | 1/4" Connector Probe - Tapered Lenke |
| M719GL11320 | 1/4" Connector Probe - Curved Lenke |
| M719GL11310 | 1/4" Connector Probe - Lenke |
| M719GM126S850 | 8.5mm Modular Short Tap - Solid |
| M719GM126S750 | 7.5mm Modular Short Tap - Solid |
| M719GM126S700 | 7.0mm Modular Short Tap - Solid |
| M719GM126S650 | 6.5mm Modular Short Tap - Solid |
| M719GM126S600 | 6.0mm Modular Short Tap - Solid |
| M719GM126S550 | 5.5mm Modular Short Tap - Solid |
| M719GM126S500 | 5.0mm Modular Short Tap - Solid |
| M719GM126S450 | 4.5mm Modular Short Tap - Solid |
| M719GM122S850 | 8.5mm Solid Modular Tap |
| M719GM122S750 | 7.5mm Solid Modular Tap |
Trademark Results [TiLock]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TILOCK 71524635 0538827 Dead/Expired |
TILO ROOFING COMPANY, INC. 1947-06-21 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.