IdentiTi
GUDID 00190376542478
CERVICAL TRIAL, 13 x 18 x 15 mm, 5°
ALPHATEC SPINE, INC.
Spinal implant trial| Primary Device ID | 00190376542478 |
| NIH Device Record Key | 978e758f-8c87-4b32-a013-c30395039238 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IdentiTi |
| Version Model Number | 127-10-13181505 |
| Company DUNS | 602465783 |
| Company Name | ALPHATEC SPINE, INC. |
| 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(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com |
Device Dimensions
| Width | 18 Millimeter |
| Height | 13 Millimeter |
| Depth | 15 Millimeter |
| Angle | 5 degree |
| Width | 18 Millimeter |
| Height | 13 Millimeter |
| Depth | 15 Millimeter |
| Angle | 5 degree |
| Width | 18 Millimeter |
| Height | 13 Millimeter |
| Depth | 15 Millimeter |
| Angle | 5 degree |
| Width | 18 Millimeter |
| Height | 13 Millimeter |
| Depth | 15 Millimeter |
| Angle | 5 degree |
| Width | 18 Millimeter |
| Height | 13 Millimeter |
| Depth | 15 Millimeter |
| Angle | 5 degree |
| Width | 18 Millimeter |
| Height | 13 Millimeter |
| Depth | 15 Millimeter |
| Angle | 5 degree |
| Width | 18 Millimeter |
| Height | 13 Millimeter |
| Depth | 15 Millimeter |
| Angle | 5 degree |
| Width | 18 Millimeter |
| Height | 13 Millimeter |
| Depth | 15 Millimeter |
| Angle | 5 degree |
| Width | 18 Millimeter |
| Height | 13 Millimeter |
| Depth | 15 Millimeter |
| Angle | 5 degree |
| Width | 18 Millimeter |
| Height | 13 Millimeter |
| Depth | 15 Millimeter |
| Angle | 5 degree |
| Width | 18 Millimeter |
| Height | 13 Millimeter |
| Depth | 15 Millimeter |
| Angle | 5 degree |
| Width | 18 Millimeter |
| Height | 13 Millimeter |
| Depth | 15 Millimeter |
| Angle | 5 degree |
| Width | 18 Millimeter |
| Height | 13 Millimeter |
| Depth | 15 Millimeter |
| Angle | 5 degree |
| Width | 18 Millimeter |
| Height | 13 Millimeter |
| Depth | 15 Millimeter |
| Angle | 5 degree |
| Width | 18 Millimeter |
| Height | 13 Millimeter |
| Depth | 15 Millimeter |
| Angle | 5 degree |
| Width | 18 Millimeter |
| Height | 13 Millimeter |
| Depth | 15 Millimeter |
| Angle | 5 degree |
| Width | 18 Millimeter |
| Height | 13 Millimeter |
| Depth | 15 Millimeter |
| Angle | 5 degree |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190376542478 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K233640
FDA Product Code
| ODP | Intervertebral fusion device with bone graft, cervical |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190376542478]
Moist Heat or Steam Sterilization
[00190376542478]
Moist Heat or Steam Sterilization
[00190376542478]
Moist Heat or Steam Sterilization
[00190376542478]
Moist Heat or Steam Sterilization
[00190376542478]
Moist Heat or Steam Sterilization
[00190376542478]
Moist Heat or Steam Sterilization
[00190376542478]
Moist Heat or Steam Sterilization
[00190376542478]
Moist Heat or Steam Sterilization
[00190376542478]
Moist Heat or Steam Sterilization
[00190376542478]
Moist Heat or Steam Sterilization
[00190376542478]
Moist Heat or Steam Sterilization
[00190376542478]
Moist Heat or Steam Sterilization
[00190376542478]
Moist Heat or Steam Sterilization
[00190376542478]
Moist Heat or Steam Sterilization
[00190376542478]
Moist Heat or Steam Sterilization
[00190376542478]
Moist Heat or Steam Sterilization
[00190376542478]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-10 |
| Device Publish Date | 2024-06-02 |
On-Brand Devices [IdentiTi]
| 00190376182452 | IdentiTi Cervical Porous Ti Spacer, 8 x 14 x 12 mm, 7° |
| 00190376182360 | IdentiTi Cervical Porous Ti Spacer, 7 x 18 x 16 mm, 10° |
| 00190376182353 | IdentiTi Cervical Porous Ti Spacer, 7 x 18 x 16 mm, 7° |
| 00190376182308 | IdentiTi Cervical Porous Ti Spacer, 7 x 16 x 14 mm, 10° |
| 00190376182292 | IdentiTi Cervical Porous Ti Spacer, 7 x 16 x 14 mm, 7° |
| 00190376182254 | IdentiTi Cervical Porous Ti Spacer, 6 x 18 x 16 mm, 10° |
| 00190376182247 | IdentiTi Cervical Porous Ti Spacer, 6 x 18 x 16 mm, 7° |
| 00190376182209 | IdentiTi Cervical Porous Ti Spacer, 6 x 16 x 14 mm, 10° |
| 00190376182193 | IdentiTi Cervical Porous Ti Spacer, 6 x 16 x 14 mm, 7° |
| 00190376182131 | IdentiTi Cervical Porous Ti Spacer, 6 x 14 x 12 mm, 7° |
| 00190376182070 | IdentiTi Cervical Porous Ti Spacer, 5 x 18 x 16 mm, 7° |
| 00190376182049 | IdentiTi Cervical Porous Ti Spacer, 5 x 16 x 14 mm, 7° |
| 00190376180939 | IdentiTi Cervical Porous Ti Spacer, 9 x 18 x 16 mm, 10° |
| 00190376180922 | IdentiTi Cervical Porous Ti Spacer, 9 x 18 x 16 mm, 7° |
| 00190376180878 | IdentiTi Cervical Porous Ti Spacer, 9 x 16 x 14 mm, 10° |
| 00190376180861 | IdentiTi Cervical Porous Ti Spacer, 9 x 16 x 14 mm, 7° |
| 00190376180809 | IdentiTi Cervical Porous Ti Spacer, 9 x 14 x 12 mm, 7° |
| 00190376180694 | IdentiTi Cervical Porous Ti Spacer, 8 x 18 x 16 mm, 10° |
| 00190376180687 | IdentiTi Cervical Porous Ti Spacer, 8 x 18 x 16 mm, 7° |
| 00190376180632 | IdentiTi Cervical Porous Ti Spacer, 8 x 16 x 14 mm, 10° |
| 00190376180625 | IdentiTi Cervical Porous Ti Spacer, 8 x 16 x 14 mm, 7° |
| 00190376180564 | IdentiTi Cervical Porous Ti Spacer, 7 x 14 x 12 mm, 7° |
| 00190376180465 | IdentiTi Cervical Porous Ti Spacer, 5 x 14 x 12 mm, 7° |
| 00190376218625 | IDENTITi ALIF POROUS Ti SPACER, SW, 7 x 38 x 28 mm, 10° |
| 00190376218601 | IDENTITi ALIF POROUS Ti SPACER, SW, 6 x 38 x 28 mm, 30° |
| 00190376218595 | IDENTITi ALIF POROUS Ti SPACER, SW, 6 x 38 x 28 mm, 20° |
| 00190376218588 | IDENTITI ALIF POROUS TI SPACER, SW, 13 X 38 X 28 MM, 10° |
| 00190376218571 | IDENTITI ALIF POROUS TI SPACER, SW, 12 X 34 X 24 MM, 15° |
| 00190376218564 | IDENTITI ALIF POROUS TI SPACER, SW, 12 X 34 X 24 MM, 10° |
| 00190376218540 | IDENTITi ALIF POROUS Ti SPACER, SW, 11 x 38 x 28 mm, 15° |
| 00190376218533 | IDENTITi ALIF POROUS Ti SPACER, SW, 11 x 38 x 28 mm, 10° |
| 00190376218519 | IDENTITi ALIF POROUS Ti SPACER, SW, 10 x 34 x 24 mm, 15° |
| 00190376218502 | IDENTITi ALIF POROUS Ti SPACER, SW, 10 x 34 x 24 mm, 10° |
| 00190376218472 | IDENTITi ALIF POROUS Ti SPACER, SW, 9 x 38 x 28 mm, 15° |
| 00190376218465 | IDENTITi ALIF POROUS Ti SPACER, SW, 9 x 38 x 28 mm, 10° |
| 00190376218441 | IDENTITi ALIF POROUS Ti SPACER, SW, 8 x 38 x 28 mm, 30° |
| 00190376218434 | IDENTITi ALIF POROUS Ti SPACER, SW, 8 x 38 x 28 mm, 20° |
| 00190376218427 | IDENTITi ALIF POROUS Ti SPACER, SW, 8 x 34 x 24 mm, 30° |
| 00190376218410 | IDENTITi ALIF POROUS Ti SPACER, SW, 8 x 34 x 24 mm, 20° |
| 00190376218403 | IDENTITi ALIF POROUS Ti SPACER, SW, 8 x 34 x 24 mm, 15° |
| 00190376218397 | IDENTITi ALIF POROUS Ti SPACER, SW, 8 x 34 x 24 mm, 10° |
| 00190376218366 | IDENTITi ALIF POROUS Ti SPACER, SW, 7 x 38 x 28 mm, 15° |
| 00190376218359 | IDENTITi ALIF POROUS Ti SPACER, SW, 6 x 34 x 24 mm, 30° |
| 00190376218342 | IDENTITi ALIF POROUS Ti SPACER, SW, 6 x 34 x 24 mm, 20° |
| 00190376218335 | IDENTITi ALIF POROUS Ti SPACER, SW, 6 x 34 x 24 mm, 15° |
| 00190376218328 | IDENTITi ALIF POROUS Ti SPACER, SW, 6 x 34 x 24 mm, 10° |
| 00190376218304 | IDENTITi ALIF POROUS Ti SPACER, SW, 5 x 38 x 28 mm, 15° |
| 00190376218298 | IDENTITi ALIF POROUS Ti SPACER, SW, 5 x 38 x 28 mm, 10° |
| 00190376218281 | IDENTITi ALIF POROUS Ti SPACER, SW, 4 x 38 x 28 mm, 30° |
| 00190376218274 | IDENTITi ALIF POROUS Ti SPACER, SW, 4 x 38 x 28 mm, 20° |
Trademark Results [IdentiTi]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IDENTITI 97773609 not registered Live/Pending |
Identiti Resources, Ltd. 2023-01-30 |
 IDENTITI 88469099 not registered Live/Pending |
Identiti Resources, Ltd. 2019-06-11 |
 IDENTITI 77343392 3556238 Live/Registered |
ISON DISTRIBUTION, LTD 2007-12-04 |
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