| Primary Device ID | 00840180501016 |
| NIH Device Record Key | eaf2a37e-d317-41da-8892-32e26f6e62fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | General Instruments |
| Version Model Number | CI-10375 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840180501016 [Primary] |
| HWN | INSTRUMENT, COMPRESSION |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840180501016]
Moist Heat or Steam Sterilization
[00840180501016]
Moist Heat or Steam Sterilization
[00840180501016]
Moist Heat or Steam Sterilization
[00840180501016]
Moist Heat or Steam Sterilization
[00840180501016]
Moist Heat or Steam Sterilization
[00840180501016]
Moist Heat or Steam Sterilization
[00840180501016]
Moist Heat or Steam Sterilization
[00840180501016]
Moist Heat or Steam Sterilization
[00840180501016]
Moist Heat or Steam Sterilization
[00840180501016]
Moist Heat or Steam Sterilization
[00840180501016]
Moist Heat or Steam Sterilization
[00840180501016]
Moist Heat or Steam Sterilization
[00840180501016]
Moist Heat or Steam Sterilization
[00840180501016]
Moist Heat or Steam Sterilization
[00840180501016]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-18 |
| Device Publish Date | 2021-01-09 |
| 00811801037276 | Penfield 4 w/Larger Handle |
| 00811801039973 | Ball Tip Probe, Rod Holder |
| 00811801038204 | Heavy Guidewire Comb |
| 00840180501221 | SHARP COBB, UP-ANGLED 22MM |
| 00840180501214 | SHARP COBB, STRAIGHT 22MM |
| 00840180501207 | SHARP COBB, DOWN-ANGLED 18MM |
| 00840180501191 | SHARP COBB, UP-ANGLED 18MM |
| 00840180501184 | SHARP COBB, STRAIGHT 18MM |
| 00840180501177 | SHARP COBB, UP-ANGLED 12MM |
| 00840180501160 | SHARP COBB, STRAIGHT 12MM |
| 00840180501153 | 5mm Extra Wide Saddle Removal Tool |
| 00840180501146 | Larger ALIF Tamp w/Teeth |
| 00840180501139 | Size 4 Curette - Down 60Deg |
| 00840180501122 | Size 2 Curette - 15Deg Up |
| 00840180501115 | Closed Tulip Screwdriver |
| 00840180501108 | Battalion, LLIF, 4th Blade w/ Large Handle, 12mm x 230mm |
| 00840180501092 | Battalion, LLIF, 4th Blade w/ Large Handle, 12mm x 190mm |
| 00840180501085 | Battalion, LLIF, 4th Blade w/ Large Handle, 8mm x 230mm |
| 00840180501078 | Battalion, LLIF, 4th Blade w/ Large Handle, 8mm x 190mm |
| 00840180501061 | Tamp w/ Center Pin, Straight |
| 00840180501054 | Suction Cobb |
| 00840180501047 | LIF Cup Curette, Offset Up Angled, Size 0 |
| 00840180501030 | Long Plate Holder |
| 00840180501023 | Set Screw Inserter - 4" shorter |
| 00840180501016 | Modular Compress-Distract Rack - Diener QC |
| 00840180501009 | Stab and Grab Screwdriver - Short, no clip |
| 00840180500996 | 90 degree Head Turner - Extra long, large diameter |
| 00840180500989 | Slap Hammer Adapter, Large Battalion Backend |
| 00840180500972 | Slap Hammer Adapter, 1/4" Sq |
| 00840180500965 | ACDF Nerve Hook |
| 00840180500958 | Gear Shift Probe w/Radel Ball Handle |
| 00840180500941 | STIRRUP SCRAPER, UP-ANGLED DOUBLE SIDE - 18MM |
| 00840180500934 | STIRRUP SCRAPER, UP-ANGLED DOUBLE SIDE - 16MM |
| 00840180500927 | STIRRUP SCRAPER, UP-ANGLED DOUBLE SIDE - 14MM |
| 00840180500910 | STIRRUP SCRAPER, UP-ANGLED DOUBLE SIDE - 12MM |
| 00840180500903 | STIRRUP SCRAPER, SINGLE SIDE - 18MM |
| 00840180500897 | STIRRUP SCRAPER, SINGLE SIDE - 16MM |
| 00840180500880 | STIRRUP SCRAPER, SINGLE SIDE - 14MM |
| 00840180500873 | STIRRUP SCRAPER, SINGLE SIDE - 12MM |
| 00840180500866 | STIRRUP SCRAPER, UP-ANGLED - 18MM |
| 00840180500859 | STIRRUP SCRAPER, UP-ANGLED - 16MM |
| 00840180500842 | STIRRUP SCRAPER, UP-ANGLED - 14MM |
| 00840180500835 | STIRRUP SCRAPER, UP-ANGLED - 12MM |
| 00840180500828 | STIRRUP SCRAPER - 18MM |
| 00840180500811 | STIRRUP SCRAPER - 16MM |
| 00840180500804 | STIRRUP SCRAPER - 14MM |
| 00840180500798 | STIRRUP SCRAPER - 12MM |
| 00840180500781 | Distractor, 10x5x25mm-15° |
| 00840180500774 | Distractor, 9x5x25mm-15° |
| 00840180500767 | Distractor, 8x5x25mm-15° |