| Primary Device ID | 00190376364445 |
| NIH Device Record Key | e7b31465-f518-4365-9c3a-584305574314 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PSX |
| Version Model Number | 86002-1500-020-008 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190376364445 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
[00190376364445]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-01-31 |
| Device Publish Date | 2022-01-22 |
| 00190376397078 | PSX Lordotic Expandable, 12 x 18 x 30mm, 20° |
| 00190376397061 | PSX Lordotic Expandable, 12 x 18 x 25mm, 20° |
| 00190376397054 | PSX Lordotic Expandable, 12 x 14 x 30mm, 20° |
| 00190376397047 | PSX Lordotic Expandable, 12 x 14 x 25mm, 20° |
| 00190376397030 | PSX Lordotic Expandable, 12 x 10 x 30mm, 20° |
| 00190376397023 | PSX Lordotic Expandable, 12 x 10 x 25mm, 20° |
| 00190376397016 | PSX Lordotic Expandable, 11 x 18 x 30mm, 20° |
| 00190376397009 | PSX Lordotic Expandable, 11 x 18 x 25mm, 20° |
| 00190376396996 | PSX Lordotic Expandable, 11 x 14 x 30mm, 20° |
| 00190376396989 | PSX Lordotic Expandable, 11 x 14 x 25mm, 20° |
| 00190376396972 | PSX Lordotic Expandable, 11 x 10 x 30mm, 20° |
| 00190376396965 | PSX Lordotic Expandable, 11 x 10 x 25mm, 20° |
| 00190376396958 | PSX Lordotic Expandable, 10 x 18 x 30mm, 20° |
| 00190376396941 | PSX Lordotic Expandable, 10 x 18 x 25mm, 20° |
| 00190376396934 | PSX Lordotic Expandable, 10 x 14 x 30mm, 20° |
| 00190376396927 | PSX Lordotic Expandable, 10 x 14 x 25mm, 20° |
| 00190376396910 | PSX Lordotic Expandable, 10 x 10 x 30mm, 20° |
| 00190376396903 | PSX Lordotic Expandable, 10 x 10 x 25mm, 20° |
| 00190376396897 | PSX Lordotic Expandable, 9 x 18 x 30mm, 20° |
| 00190376396880 | PSX Lordotic Expandable, 9 x 18 x 25mm, 20° |
| 00190376396873 | PSX Lordotic Expandable, 9 x 14 x 30mm, 20° |
| 00190376396866 | PSX Lordotic Expandable, 9 x 14 x 25mm, 20° |
| 00190376396859 | PSX Lordotic Expandable, 9 x 10 x 30mm, 20° |
| 00190376396842 | PSX Lordotic Expandable, 9 x 10 x 25mm, 20° |
| 00190376396835 | PSX Lordotic Expandable, 8 x 18 x 30mm, 20° |
| 00190376396828 | PSX Lordotic Expandable, 8 x 18 x 25mm, 20° |
| 00190376396811 | PSX Lordotic Expandable, 8 x 14 x 30mm, 20° |
| 00190376396804 | PSX Lordotic Expandable, 8 x 14 x 25mm, 20° |
| 00190376396798 | PSX Lordotic Expandable, 8 x 10 x 30mm, 20° |
| 00190376396781 | PSX Lordotic Expandable, 8 x 10 x 25mm, 20° |
| 00190376396774 | PSX Lordotic Expandable, 7 x 18 x 30mm, 20° |
| 00190376396767 | PSX Lordotic Expandable, 7 x 18 x 25mm, 20° |
| 00190376396750 | PSX Lordotic Expandable, 7 x 14 x 30mm, 20° |
| 00190376396743 | PSX Lordotic Expandable, 7 x 14 x 25mm, 20° |
| 00190376396736 | PSX Lordotic Expandable, 7 x 10 x 30mm, 20° |
| 00190376383095 | 3/16" SQ TORQUE LIMITING T-HANDLE, 20 IN-LBS, BLACK |
| 00190376383088 | 3/16" SQ TORQUE LIMITING T-HANDLE, 20 IN-LBS, YELLOW |
| 00190376383071 | 3/16" SQ TORQUE LIMITING T-HANDLE, 20 IN-LBS, FUSCHIA |
| 00190376383064 | 3/16" SQ TORQUE LIMITING T-HANDLE, 20 IN-LBS, DARK BLUE |
| 00190376383057 | 3/16" SQ TORQUE LIMITING T-HANDLE, 20 IN-LBS, GREEN |
| 00190376383040 | 3/16" SQ TORQUE LIMITING T-HANDLE, 20 IN-LBS, DARK GREY |
| 00190376383033 | 3/16" SQ TORQUE LIMITING T-HANDLE, 20 IN-LBS, GREY |
| 00190376383026 | 3/16" SQ TORQUE LIMITING T-HANDLE, 20 IN-LBS, COOL GREY |
| 00190376364445 | 3/16" SQ TORQUE LIMITING AXIAL HANDLE, 20 IN-LBS, BLACK |
| 00190376364438 | 3/16" SQ TORQUE LIMITING AXIAL HANDLE, 20 IN-LBS, YELLOW |
| 00190376364421 | 3/16" SQ TORQUE LIMITING AXIAL HANDLE, 20 IN-LBS, FUCHSIA |
| 00190376364414 | 3/16" SQ TORQUE LIMITING AXIAL HANDLE, 20 IN-LBS, DARK BLUE |
| 00190376364407 | 3/16" SQ TORQUE LIMITING AXIAL HANDLE, 20 IN-LBS, GREEN |
| 00190376364391 | 3/16" SQ TORQUE LIMITING AXIAL HANDLE, 20 IN-LBS, DARK GREY |
| 00190376364384 | 3/16" SQ TORQUE LIMITING AXIAL HANDLE, 20 IN-LBS, GREY |