| Primary Device ID | 00190376555980 |
| NIH Device Record Key | 9ae22975-ab79-4290-9de5-f114bff0c379 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LIF Revision Instruments |
| Version Model Number | 254-06-001-05 |
| Company DUNS | 602465783 |
| Company Name | ALPHATEC SPINE, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190376555980 [Primary] |
| GDI | DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190376555980]
Moist Heat or Steam Sterilization
[00190376555980]
Moist Heat or Steam Sterilization
[00190376555980]
Moist Heat or Steam Sterilization
[00190376555980]
Moist Heat or Steam Sterilization
[00190376555980]
Moist Heat or Steam Sterilization
[00190376555980]
Moist Heat or Steam Sterilization
[00190376555980]
Moist Heat or Steam Sterilization
[00190376555980]
Moist Heat or Steam Sterilization
[00190376555980]
Moist Heat or Steam Sterilization
[00190376555980]
Moist Heat or Steam Sterilization
[00190376555980]
Moist Heat or Steam Sterilization
[00190376555980]
Moist Heat or Steam Sterilization
[00190376555980]
Moist Heat or Steam Sterilization
[00190376555980]
Moist Heat or Steam Sterilization
[00190376555980]
Moist Heat or Steam Sterilization
[00190376555980]
Moist Heat or Steam Sterilization
[00190376555980]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-15 |
| Device Publish Date | 2024-11-07 |
| 00190376643373 | LIF Alpha Revision Instruments |
| 00190376560328 | LIF Removable Impact Cap |
| 00190376556109 | Offset Osteophyter |
| 00190376556093 | LIF, Pituitary Rongeur, Bayonetted, 8mm |
| 00190376556086 | LIF, Pituitary Rongeur, Bayonetted, 7mm |
| 00190376556079 | LIF, Pituitary Rongeur, Bayonetted, 6mm |
| 00190376556062 | LIF, Pituitary Rongeur, Bayonetted, 5mm |
| 00190376556055 | LIF, Pituitary Rongeur, Bayonetted, 4mm |
| 00190376556048 | LIF, Pituitary Rongeur, Bayonetted, 3mm |
| 00190376556031 | LIF, Pituitary Rongeur, Bayonetted, 2mm |
| 00190376556024 | LIF Implant Removal Rongeur |
| 00190376556017 | LIF Revision Hook, Bayonetted 10mm |
| 00190376556000 | LIF Revision Hook, Bayonetted 7mm |
| 00190376555997 | LIF Revision Pick, 7mm |
| 00190376555980 | LIF Revision Pick, 5mm |
| 00190376555973 | LIF Revision Hook, Straight 10mm |
| 00190376555966 | LIF Revision Hook, Straight 7mm |
| 00190376555959 | Ti Implant Threaded Removal Tool, L |
| 00190376555942 | Ti Implant Threaded Removal Tool, M |
| 00190376555935 | Ti Implant Threaded Removal Tool, S |
| 00190376555928 | PEEK Implant Threaded Removal Tool, L |
| 00190376555911 | PEEK Implant Threaded Removal Tool, M |
| 00190376555904 | PEEK Implant Threaded Removal Tool, S |
| 00190376555898 | LIF Revision Drill |
| 00190376555881 | LIF Revision Drill Guide |