Ascend
GUDID 00190376519869
12 mm CORE ENDPLATE, LAT 22 x 55 mm 5°
ALPHATEC SPINE, INC.
Vertebral body prosthesis| Primary Device ID | 00190376519869 |
| NIH Device Record Key | 71c40cbd-00f7-4c36-b70a-9119c4032f61 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ascend |
| Version Model Number | 153-12-L-225505-S |
| Company DUNS | 602465783 |
| Company Name | ALPHATEC SPINE, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | +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
| Depth | 22 Millimeter |
| Width | 55 Millimeter |
| Angle | 5 degree |
| Depth | 22 Millimeter |
| Width | 55 Millimeter |
| Angle | 5 degree |
| Depth | 22 Millimeter |
| Width | 55 Millimeter |
| Angle | 5 degree |
| Depth | 22 Millimeter |
| Width | 55 Millimeter |
| Angle | 5 degree |
| Depth | 22 Millimeter |
| Width | 55 Millimeter |
| Angle | 5 degree |
| Depth | 22 Millimeter |
| Width | 55 Millimeter |
| Angle | 5 degree |
| Depth | 22 Millimeter |
| Width | 55 Millimeter |
| Angle | 5 degree |
| Depth | 22 Millimeter |
| Width | 55 Millimeter |
| Angle | 5 degree |
| Depth | 22 Millimeter |
| Width | 55 Millimeter |
| Angle | 5 degree |
| Depth | 22 Millimeter |
| Width | 55 Millimeter |
| Angle | 5 degree |
| Depth | 22 Millimeter |
| Width | 55 Millimeter |
| Angle | 5 degree |
| Depth | 22 Millimeter |
| Width | 55 Millimeter |
| Angle | 5 degree |
| Depth | 22 Millimeter |
| Width | 55 Millimeter |
| Angle | 5 degree |
| Depth | 22 Millimeter |
| Width | 55 Millimeter |
| Angle | 5 degree |
| Depth | 22 Millimeter |
| Width | 55 Millimeter |
| Angle | 5 degree |
| Depth | 22 Millimeter |
| Width | 55 Millimeter |
| Angle | 5 degree |
| Depth | 22 Millimeter |
| Width | 55 Millimeter |
| Angle | 5 degree |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190376519869 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K232173
FDA Product Code
| PLR | Spinal vertebral body replacement device - Cervical |
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 | 2024-11-05 |
| Device Publish Date | 2024-10-28 |
On-Brand Devices [Ascend]
| 00190376544892 | Ascend TL VBR Instruments A |
| 00190376544885 | Ascend TL VBR Instruments B |
| 00190376523576 | TL VBR DISTRACTOR HANDLE |
| 00190376523316 | 16 mm STATIC CORE, 26 mm |
| 00190376523309 | 16 mm STATIC CORE, 22 mm |
| 00190376523293 | 16 mm STATIC CORE, 18 mm |
| 00190376522012 | TL VBR 16 mm CORE REMOVAL TOOL |
| 00190376521572 | 16 mm CORE ENDPLATE, BAN 18 x 50 mm 10° |
| 00190376521565 | 16 mm CORE ENDPLATE, BAN 18 x 50 mm 5° |
| 00190376521558 | 16 mm CORE ENDPLATE, BAN 18 x 50 mm 0° |
| 00190376521541 | 16 mm CORE ENDPLATE, BAN 18 x 45 mm 10° |
| 00190376521534 | 16 mm CORE ENDPLATE, BAN 18 x 45 mm 5° |
| 00190376521527 | 16 mm CORE ENDPLATE, BAN 18 x 45 mm 0° |
| 00190376521473 | 16 mm CORE ENDPLATE, BAN 18 x 40 mm 10° |
| 00190376521466 | 16 mm CORE ENDPLATE, BAN 18 x 40 mm 5° |
| 00190376521459 | 16 mm CORE ENDPLATE, BAN 18 x 40 mm 0° |
| 00190376521442 | 16 mm CORE ENDPLATE, BAN 18 x 35 mm 10° |
| 00190376521435 | 16 mm CORE ENDPLATE, BAN 18 x 35 mm 5° |
| 00190376521428 | 16 mm CORE ENDPLATE, BAN 18 x 35 mm 0° |
| 00190376521411 | 16 mm CORE ENDPLATE, BAN 18 x 30 mm 10° |
| 00190376521404 | 16 mm CORE ENDPLATE, BAN 18 x 30 mm 5° |
| 00190376521398 | 16 mm CORE ENDPLATE, BAN 18 x 30 mm 0° |
| 00190376521381 | 16 mm CORE ENDPLATE, BAN 18 x 25 mm 10° |
| 00190376521367 | 16 mm CORE ENDPLATE, BAN 18 x 25 mm 0° |
| 00190376521350 | 16 mm CORE ENDPLATE, BAN 16 x 50 mm 10° |
| 00190376521343 | 16 mm CORE ENDPLATE, BAN 16 x 50 mm 5° |
| 00190376521336 | 16 mm CORE ENDPLATE, BAN 16 x 50 mm 0° |
| 00190376521329 | 16 mm CORE ENDPLATE, BAN 16 x 45 mm 10° |
| 00190376521312 | 16 mm CORE ENDPLATE, BAN 16 x 45 mm 5° |
| 00190376521305 | 16 mm CORE ENDPLATE, BAN 16 x 45 mm 0° |
| 00190376521299 | 16 mm CORE ENDPLATE, BAN 16 x 40 mm 10° |
| 00190376521282 | 16 mm CORE ENDPLATE, BAN 16 x 40 mm 5° |
| 00190376521275 | 16 mm CORE ENDPLATE, BAN 16 x 40 mm 0° |
| 00190376521268 | 16 mm CORE ENDPLATE, BAN 16 x 35 mm 10° |
| 00190376521251 | 16 mm CORE ENDPLATE, BAN 16 x 35 mm 5° |
| 00190376521244 | 16 mm CORE ENDPLATE, BAN 16 x 35 mm 0° |
| 00190376521237 | 16 mm CORE ENDPLATE, BAN 16 x 30 mm 10° |
| 00190376521220 | 16 mm CORE ENDPLATE, BAN 16 x 30 mm 5° |
| 00190376521213 | 16 mm CORE ENDPLATE, BAN 16 x 30 mm 0° |
| 00190376521206 | 16 mm CORE ENDPLATE, BAN 16 x 25 mm 10° |
| 00190376521190 | 16 mm CORE ENDPLATE, BAN 16 x 25 mm 5° |
| 00190376521183 | 16 mm CORE ENDPLATE, BAN 16 x 25 mm 0° |
| 00190376520896 | 16 mm CORE ENDPLATE, LAT 22 x 60 mm 10° |
| 00190376520889 | 16 mm CORE ENDPLATE, LAT 22 x 60 mm 5° |
| 00190376520872 | 16 mm CORE ENDPLATE, LAT 22 x 60 mm 0° |
| 00190376520865 | 16 mm CORE ENDPLATE, LAT 22 x 55 mm 10° |
| 00190376520858 | 16 mm CORE ENDPLATE, LAT 22 x 55 mm 5° |
| 00190376520841 | 16 mm CORE ENDPLATE, LAT 22 x 55 mm 0° |
| 00190376520834 | 16 mm CORE ENDPLATE, LAT 22 x 50 mm 10° |
| 00190376520810 | 16 mm CORE ENDPLATE, LAT 22 x 50 mm 0° |
Trademark Results [Ascend]
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