TrueLok 99-56-13590
GUDID 18053340349536
TL PLUS FOOTPLATE 120MM STERILE
ORTHOFIX SRL
External orthopaedic fixation system, single-use, sterile| Primary Device ID | 18053340349536 |
| NIH Device Record Key | b01233b9-4052-4fb4-8ae2-748841bf9406 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TrueLok |
| Version Model Number | 1 |
| Catalog Number | 99-56-13590 |
| Company DUNS | 438793622 |
| Company Name | ORTHOFIX SRL |
| 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 | true |
| Expiration Date | true |
| 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 | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it | |
| Phone | 0456719000 |
| info@orthofix.it |
Device Dimensions
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
| Lumen/Inner Diameter | 120 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18053340349536 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K941048
FDA Product Code
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-25 |
| Device Publish Date | 2021-06-17 |
On-Brand Devices [TrueLok]
| 18053340349529 | TL+ FOOTPLATE 100MM STERILE |
| 18053340349512 | TL PLUS FIVE EIGHTHS RING 200MM STERILE |
| 18053340349505 | TL PLUS FIVE EIGHTHS RING 180MM STERILE |
| 18053340349499 | TL PLUS FIVE EIGHTHS RING 170MM STERILE |
| 18053340349482 | TL PLUS FIVE EIGHTHS RING 160MM STERILE |
| 18053340349475 | TL PLUS FIVE EIGHTHS RING 150MM STERILE |
| 18053340349468 | TL PLUS FIVE EIGHTHS RING 140MM STERILE |
| 18053340349451 | TL PLUS FIVE EIGHTHS RING 130MM STERILE |
| 18053340349444 | TL PLUS FIVE EIGHTHS RING 120MM STERILE |
| 18053340349437 | TL PLUS FIVE EIGHTHS RING 100MM STERILE |
| 18053340349420 | TL PLUS HALF RING 240MM STERILE |
| 18053340349413 | TL PLUS HALF RING 220MM STERILE |
| 18053340349406 | TL PLUS HALF RING 200MM STERILE |
| 18053340349390 | TL PLUS HALF RING 180MM STERILE |
| 18053340349383 | TL PLUS HALF RING 170MM STERILE |
| 18053340349376 | TL PLUS HALF RING 160MM STERILE |
| 18053340349369 | TL PLUS HALF RING 150MM STERILE |
| 18053340349352 | TL PLUS HALF RING 140MM STERILE |
| 18053340349345 | TL PLUS HALF RING 130MM STERILE |
| 18053340349338 | TL PLUS HALF RING 120MM STERILE |
| 18053340349321 | TL PLUS HALF RING 100MM STERILE |
| 18053340349314 | TL PLUS HALF RING 80MM STERILE |
| 18053340349307 | TL PLUS FULL RING, 240MM STERILE |
| 18053340349291 | TL PLUS FULL RING, 220MM STERILE |
| 18053340349284 | TL PLUS FULL RING, 200MM STERILE |
| 18053340349277 | TL PLUS FULL RING, 180MM STERILE |
| 18053340349260 | TL PLUS FULL RING, 170MM STERILE |
| 18053340349253 | TL PLUS FULL RING, 160MM STERILE |
| 18053340349246 | TL PLUS FULL RING, 150MM STERILE |
| 18053340349239 | TL PLUS FULL RING, 140MM STERILE |
| 18053340349222 | TL PLUS FULL RING, 130MM STERILE |
| 18053340349215 | TL PLUS FULL RING, 120MM STERILE |
| 18053340349208 | TL PLUS FULL RING 100MM STERILE |
| 18053340349192 | TL PLUS FULL RING 80MM STERILE |
| 18053340349673 | TL TRAUMA STRUT STERILE |
| 18053340349666 | TRUE LOK TRAUMA U-SUPPORT, 180MM STERILE |
| 18053340349659 | TRUE LOK TRAUMA U-SUPPORT, 160MM STERILE |
| 18053340349642 | 200 MM DOUBLE ROW FOOT PLATE STERILE |
| 18053340349635 | TL+ FOOTPLATE 200MM STERILE |
| 18053340349628 | 180 MM DOUBLE ROW FOOT PLATE STERILE |
| 18053340349611 | TL+ FOOTPLATE 180MM STERILE |
| 18053340349604 | TL+ FOOTPLATE 170MM STERILE |
| 18053340349598 | 160 MM DOUBLE ROW FOOT PLATE STERILE |
| 18053340349581 | TL+ FOOTPLATE 160MM STERILE |
| 18053340349574 | 150 MM DOUBLE ROW FOOT PLATE STERILE |
| 18053340349567 | TL PLUS FOOTPLATE 150MM STERILE |
| 18053340349550 | TL+ FOOTPLATE 140MM STERILE |
| 18053340349543 | TL+ FOOTPLATE 130MM STERILE |
| 18053340349536 | TL PLUS FOOTPLATE 120MM STERILE |
| 18052469472880 | TRUELOK FOOT LEG ALIGNMENT SUPPORT PACK OF 3 STERILE |
Trademark Results [TrueLok]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRUELOK 97044556 not registered Live/Pending |
Texas Scottish Rite Hospital for Crippled Children 2021-09-24 |
 TRUELOK 85232653 4028273 Live/Registered |
CMAX-2000, INC. 2011-02-02 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.