| Primary Device ID | 00844856009325 |
| NIH Device Record Key | 873eed8c-2fb1-428b-b82e-e62009d414ad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Novel Spinal Spacer System |
| Version Model Number | 64301-116 |
| 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 | 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 |
| Phone | +1(760)494-6840 |
| mfunk@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 | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com |
| Width | 16 Millimeter |
| Width | 16 Millimeter |
| Width | 16 Millimeter |
| Width | 16 Millimeter |
| Height | 16 Millimeter |
| Length | 26 Millimeter |
| Angle | 5 degree |
| Width | 16 Millimeter |
| Height | 16 Millimeter |
| Length | 26 Millimeter |
| Angle | 5 degree |
| Width | 16 Millimeter |
| Height | 16 Millimeter |
| Length | 26 Millimeter |
| Angle | 5 degree |
| Width | 16 Millimeter |
| Height | 16 Millimeter |
| Length | 26 Millimeter |
| Angle | 5 degree |
| Width | 16 Millimeter |
| Height | 16 Millimeter |
| Length | 26 Millimeter |
| Angle | 5 degree |
| Width | 16 Millimeter |
| Height | 16 Millimeter |
| Length | 26 Millimeter |
| Angle | 5 degree |
| Width | 16 Millimeter |
| Height | 16 Millimeter |
| Length | 26 Millimeter |
| Angle | 5 degree |
| Width | 16 Millimeter |
| Height | 16 Millimeter |
| Length | 26 Millimeter |
| Angle | 5 degree |
| Width | 16 Millimeter |
| Height | 16 Millimeter |
| Length | 26 Millimeter |
| Angle | 5 degree |
| Width | 16 Millimeter |
| Height | 16 Millimeter |
| Length | 26 Millimeter |
| Angle | 5 degree |
| Width | 16 Millimeter |
| Height | 16 Millimeter |
| Length | 26 Millimeter |
| Angle | 5 degree |
| Width | 16 Millimeter |
| Height | 16 Millimeter |
| Length | 26 Millimeter |
| Angle | 5 degree |
| Width | 16 Millimeter |
| Height | 16 Millimeter |
| Length | 26 Millimeter |
| Angle | 5 degree |
| Width | 16 Millimeter |
| Height | 16 Millimeter |
| Length | 26 Millimeter |
| Angle | 5 degree |
| Width | 16 Millimeter |
| Height | 16 Millimeter |
| Length | 26 Millimeter |
| Angle | 5 degree |
| Width | 16 Millimeter |
| Height | 16 Millimeter |
| Length | 26 Millimeter |
| Angle | 5 degree |
| Width | 16 Millimeter |
| Height | 16 Millimeter |
| Length | 26 Millimeter |
| Angle | 5 degree |
| Width | 16 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00844856009325 [Primary] |
| MQP | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00844856009325]
Moist Heat or Steam Sterilization
[00844856009325]
Moist Heat or Steam Sterilization
[00844856009325]
Moist Heat or Steam Sterilization
[00844856009325]
Moist Heat or Steam Sterilization
[00844856009325]
Moist Heat or Steam Sterilization
[00844856009325]
Moist Heat or Steam Sterilization
[00844856009325]
Moist Heat or Steam Sterilization
[00844856009325]
Moist Heat or Steam Sterilization
[00844856009325]
Moist Heat or Steam Sterilization
[00844856009325]
Moist Heat or Steam Sterilization
[00844856009325]
Moist Heat or Steam Sterilization
[00844856009325]
Moist Heat or Steam Sterilization
[00844856009325]
Moist Heat or Steam Sterilization
[00844856009325]
Moist Heat or Steam Sterilization
[00844856009325]
Moist Heat or Steam Sterilization
[00844856009325]
Moist Heat or Steam Sterilization
[00844856009325]
Moist Heat or Steam Sterilization
[00844856009325]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-08-31 |
| 00844856066861 | Novel SD, Self Distracting PEEK Cage, Wide, Novel, L, 20 mm |
| 00844856066854 | Novel SD, Self Distracting PEEK Cage, Wide, Novel, L, 19 mm |
| 00844856066847 | Novel SD, Self Distracting PEEK Cage, Wide, Novel, L, 18 mm |
| 00844856066830 | Novel SD, Self Distracting PEEK Cage, Wide, Novel, L, 17 mm |
| 00844856066823 | Novel SD, Self Distracting PEEK Cage, Wide, Novel, L, 16 mm |
| 00844856066816 | Novel SD, Self Distracting PEEK Cage, Wide, Novel, L, 8 mm |
| 00844856066809 | Novel SD, Self Distracting PEEK Cage, Wide, Novel, M, 20 mm |
| 00844856066793 | Novel SD, Self Distracting PEEK Cage, Wide, Novel, M, 19 mm |
| 00844856066786 | Novel SD, Self Distracting PEEK Cage, Wide, Novel, M, 18 mm |
| 00844856066779 | Novel SD, Self Distracting PEEK Cage, Wide, Novel, M, 17 mm |
| 00844856066762 | Novel SD, Self Distracting PEEK Cage, Wide, Novel, M, 16 mm |
| 00844856066755 | Novel SD, Self Distracting PEEK Cage, Wide, Novel, M, 8 mm |
| 00844856066748 | Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 20 mm |
| 00844856066731 | Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 19 mm |
| 00844856066724 | Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 18 mm |
| 00844856066717 | Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 17 mm |
| 00844856066700 | Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 16 mm |
| 00844856066694 | Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 15 mm |
| 00844856066687 | Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 14 mm |
| 00844856066670 | Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 13 mm |
| 00844856066663 | Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 12 mm |
| 00844856066656 | Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 11 mm |
| 00844856066649 | Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 10 mm |
| 00844856066632 | Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 9 mm |
| 00844856066625 | Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 8 mm |
| 00844856066601 | Novel SD, Self Distracting PEEK Cage, Novel, Large, 20 mm |
| 00844856066588 | Novel SD, Self Distracting PEEK Cage, Novel, Large, 19 mm |
| 00844856066564 | Novel SD, Self Distracting PEEK Cage, Novel, Large, 18 mm |
| 00844856066540 | Novel SD, Self Distracting PEEK Cage, Novel, Large, 17 mm |
| 00844856066526 | Novel SD, Large, 16mm, PEEK |
| 00844856066427 | Self Distracting PEEK Cage, Novel, Medium, 20 mm |
| 00844856066403 | Self Distracting PEEK Cage, Novel, Medium, 19 mm |
| 00844856066380 | Self Distracting PEEK Cage, Novel, Medium, 18 mm |
| 00844856066366 | Self Distracting PEEK Cage, Novel, Medium, 17 mm |
| 00844856066342 | Novel SD, Medium, 16mm, PEEK |
| 00844856066243 | Novel SD,Self Distracting PEEK Cage, Novel, Small, 20 mm |
| 00844856066229 | Novel SD,Self Distracting PEEK Cage, Novel, Small, 19 mm |
| 00844856066205 | Novel SD,Self Distracting PEEK Cage, Novel, Small, 18 mm |
| 00844856066182 | Novel SD,Self Distracting PEEK Cage, Novel, Small, 17 mm |
| 00844856066168 | Novel SD, Small, 16mm, PEEK |
| 00844856066076 | Novel Cervical Spacer, 12 mm Large, 7deg Lordotic, Titanium |
| 00844856066069 | Novel Cervical Spacer, 11 mm Large, 7deg Lordotic, Titanium |
| 00844856066052 | Novel Cervical Spacer, 10 mm Large, 7deg Lordotic, Titanium |
| 00844856066045 | Novel Cervical Spacer, 9 mm Large, 7deg Lordotic, Titanium |
| 00844856066038 | Novel Cervical Spacer, 8 mm Large, 7deg Lordotic, Titanium |
| 00844856066021 | Novel Cervical Spacer, 7 mm Large, 7deg Lordotic, Titanium |
| 00844856066014 | Novel Cervical Spacer, 6 mm Large, 7deg Lordotic, Titanium |
| 00844856066007 | Novel Cervical Spacer, 5 mm Large, 7deg Lordotic, Titanium |
| 00844856065994 | Novel Cervical Spacer, 12 mm Large, 7deg Lordotic, PEEK |
| 00844856065987 | Novel Cervical Spacer, 11 mm Large, 7deg Lordotic, PEEK |