Primary Device ID | 00190376518374 |
NIH Device Record Key | 1683d93b-aad8-4555-9c60-f812dec65d41 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Ascend |
Version Model Number | 153-12-T-181607-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 |
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 |
Depth | 18 Millimeter |
Width | 16 Millimeter |
Angle | 7 degree |
Depth | 18 Millimeter |
Width | 16 Millimeter |
Angle | 7 degree |
Depth | 18 Millimeter |
Width | 16 Millimeter |
Angle | 7 degree |
Depth | 18 Millimeter |
Width | 16 Millimeter |
Angle | 7 degree |
Depth | 18 Millimeter |
Width | 16 Millimeter |
Angle | 7 degree |
Depth | 18 Millimeter |
Width | 16 Millimeter |
Angle | 7 degree |
Depth | 18 Millimeter |
Width | 16 Millimeter |
Angle | 7 degree |
Depth | 18 Millimeter |
Width | 16 Millimeter |
Angle | 7 degree |
Depth | 18 Millimeter |
Width | 16 Millimeter |
Angle | 7 degree |
Depth | 18 Millimeter |
Width | 16 Millimeter |
Angle | 7 degree |
Depth | 18 Millimeter |
Width | 16 Millimeter |
Angle | 7 degree |
Depth | 18 Millimeter |
Width | 16 Millimeter |
Angle | 7 degree |
Depth | 18 Millimeter |
Width | 16 Millimeter |
Angle | 7 degree |
Depth | 18 Millimeter |
Width | 16 Millimeter |
Angle | 7 degree |
Depth | 18 Millimeter |
Width | 16 Millimeter |
Angle | 7 degree |
Depth | 18 Millimeter |
Width | 16 Millimeter |
Angle | 7 degree |
Depth | 18 Millimeter |
Width | 16 Millimeter |
Angle | 7 degree |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00190376518374 [Primary] |
PLR | Spinal vertebral body replacement device - Cervical |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-11-05 |
Device Publish Date | 2024-10-28 |
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° |