T-PAL™ ProTi 360°™ 108812008
GUDID 00819917021639
Tyber Medical LLC
Metal-polymer composite spinal interbody fusion cage| Primary Device ID | 00819917021639 |
| NIH Device Record Key | 3cffa617-1967-4f0b-8ac4-1aa4eff2b89a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | T-PAL™ ProTi 360°™ |
| Version Model Number | 108812008 |
| Catalog Number | 108812008 |
| Company DUNS | 010968002 |
| Company Name | Tyber Medical 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 | 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00819917021639 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K172185
FDA Product Code
| MAX | Intervertebral fusion device with bone graft, lumbar |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2018-04-14 |
On-Brand Devices [T-PAL™ ProTi 360°™]
| 00819917021837 | 108812217 |
| 00819917021820 | 108812216 |
| 00819917021813 | 108812215 |
| 00819917021806 | 108812214 |
| 00819917021790 | 108812213 |
| 00819917021783 | 108812212 |
| 00819917021776 | 108812211 |
| 00819917021769 | 108812210 |
| 00819917021752 | 108812209 |
| 00819917021745 | 108812208 |
| 00819917021738 | 108812207 |
| 00819917021721 | 108812017 |
| 00819917021714 | 108812016 |
| 00819917021707 | 108812015 |
| 00819917021691 | 108812014 |
| 00819917021684 | 108812013 |
| 00819917021677 | 108812012 |
| 00819917021660 | 108812011 |
| 00819917021653 | 108812010 |
| 00819917021646 | 108812009 |
| 00819917021639 | 108812008 |
| 00819917021622 | 108812007 |
Trademark Results [T-PAL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 T-PAL 88594038 not registered Live/Pending |
DePuy Synthes, Inc. 2019-08-27 |
 T-PAL 77026677 not registered Dead/Abandoned |
MedApps, Inc. 2006-10-22 |
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