TRIALTIS 5560646020
GUDID 10705034596853
ø5.5-6mm to 6mm x 20mm
DEPUY SPINE, LLC
Bone-screw internal spinal fixation system connector| Primary Device ID | 10705034596853 |
| NIH Device Record Key | fde8553b-7fb5-453e-b958-af5cd47f0f10 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRIALTIS |
| Version Model Number | 5560-64-6020 |
| Catalog Number | 5560646020 |
| Company DUNS | 107105876 |
| Company Name | DEPUY SPINE, 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 |
Customer Support Contacts
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705034596853 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K242042
FDA Product Code
| NKB | Thoracolumbosacral pedicle screw system |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10705034596853]
Moist Heat or Steam Sterilization
[10705034596853]
Moist Heat or Steam Sterilization
[10705034596853]
Moist Heat or Steam Sterilization
[10705034596853]
Moist Heat or Steam Sterilization
[10705034596853]
Moist Heat or Steam Sterilization
[10705034596853]
Moist Heat or Steam Sterilization
[10705034596853]
Moist Heat or Steam Sterilization
[10705034596853]
Moist Heat or Steam Sterilization
[10705034596853]
Moist Heat or Steam Sterilization
[10705034596853]
Moist Heat or Steam Sterilization
[10705034596853]
Moist Heat or Steam Sterilization
[10705034596853]
Moist Heat or Steam Sterilization
[10705034596853]
Moist Heat or Steam Sterilization
[10705034596853]
Moist Heat or Steam Sterilization
[10705034596853]
Moist Heat or Steam Sterilization
[10705034596853]
Moist Heat or Steam Sterilization
[10705034596853]
Moist Heat or Steam Sterilization
[10705034596853]
Moist Heat or Steam Sterilization
[10705034596853]
Moist Heat or Steam Sterilization
[10705034596853]
Moist Heat or Steam Sterilization
[10705034596853]
Moist Heat or Steam Sterilization
[10705034596853]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-28 |
| Device Publish Date | 2024-11-20 |
On-Brand Devices [TRIALTIS]
| 10705034596877 | ø5.5-6mm to 6mm x 60mm |
| 10705034596860 | ø5.5-6mm to 6mm x 40mm |
| 10705034596853 | ø5.5-6mm to 6mm x 20mm |
Trademark Results [TRIALTIS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRIALTIS 97257918 not registered Live/Pending |
DePuy Synthes, Inc. 2022-02-08 |
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