| Primary Device ID | 00190376588483 |
| NIH Device Record Key | e51992be-ff1f-4b7f-8c13-1a224fb138a0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMP II |
| Version Model Number | 614-100 |
| 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 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00190376588483 [Primary] |
| OVD | Intervertebral fusion device with integrated fixation, lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190376588483]
Moist Heat or Steam Sterilization
[00190376588483]
Moist Heat or Steam Sterilization
[00190376588483]
Moist Heat or Steam Sterilization
[00190376588483]
Moist Heat or Steam Sterilization
[00190376588483]
Moist Heat or Steam Sterilization
[00190376588483]
Moist Heat or Steam Sterilization
[00190376588483]
Moist Heat or Steam Sterilization
[00190376588483]
Moist Heat or Steam Sterilization
[00190376588483]
Moist Heat or Steam Sterilization
[00190376588483]
Moist Heat or Steam Sterilization
[00190376588483]
Moist Heat or Steam Sterilization
[00190376588483]
Moist Heat or Steam Sterilization
[00190376588483]
Moist Heat or Steam Sterilization
[00190376588483]
Moist Heat or Steam Sterilization
[00190376588483]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-28 |
| Device Publish Date | 2025-03-20 |
| 00190376649597 | Bone Screwdriver, Stab n Grab Offset |
| 00190376643267 | Implant Guide Clip, LTP |
| 00190376635538 | AMP II Plate and Center Screw, 2-Hole, 10 |
| 00190376635521 | AMP II Plate and Center Screw, 2-Hole, 08 |
| 00190376635514 | AMP II Plate and Center Screw, 2-Hole, 06 |
| 00190376635507 | AMP II Plate and Center Screw, 2-Hole, 04 |
| 00190376635484 | AMP II Plate and Center Screw, 1-Hole, 10 |
| 00190376635477 | AMP II Plate and Center Screw, 1-Hole, 08 |
| 00190376635460 | AMP II Plate and Center Screw, 1-Hole, 06 |
| 00190376635453 | AMP II Plate and Center Screw, 1-Hole, 04 |
| 00190376610467 | AMP II Removal Tool |
| 00190376588582 | Bone Screwdriver, Active |
| 00190376588575 | Awl, Offset |
| 00190376588551 | Implant Guide Clip, PTP |
| 00190376588544 | AMP II Center Screw Driver, Short |
| 00190376588537 | AMP II Center Screw Driver, Ball Hex |
| 00190376588520 | AMP II In-Situ Inserter, C/C |
| 00190376588513 | AMP II In-Situ Inserter |
| 00190376588506 | AMP II Inserter Sleeve, M/L |
| 00190376588490 | AMP II Inserter Sleeve, C/C |
| 00190376588483 | AMP II Inserter Sleeve |