| Primary Device ID | 00840311233243 |
| NIH Device Record Key | 4a0b7612-887b-4a91-a76e-75ff5668d458 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Contact ALP |
| Version Model Number | 725-017 |
| Company DUNS | 014520584 |
| Company Name | Surgalign Spine Technologies, 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(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840311233243 [Primary] |
| HXX | SCREWDRIVER |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840311233243]
Moist Heat or Steam Sterilization
[00840311233243]
Moist Heat or Steam Sterilization
[00840311233243]
Moist Heat or Steam Sterilization
[00840311233243]
Moist Heat or Steam Sterilization
[00840311233243]
Moist Heat or Steam Sterilization
[00840311233243]
Moist Heat or Steam Sterilization
[00840311233243]
Moist Heat or Steam Sterilization
[00840311233243]
Moist Heat or Steam Sterilization
[00840311233243]
Moist Heat or Steam Sterilization
[00840311233243]
Moist Heat or Steam Sterilization
[00840311233243]
Moist Heat or Steam Sterilization
[00840311233243]
Moist Heat or Steam Sterilization
[00840311233243]
Moist Heat or Steam Sterilization
[00840311233243]
Moist Heat or Steam Sterilization
[00840311233243]
Moist Heat or Steam Sterilization
[00840311233243]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-21 |
| Device Publish Date | 2023-06-13 |
| 00840311233151 | 54mm Anterior Sacral Plate |
| 00840311233144 | 52mm Anterior Sacral Plate |
| 00840311233137 | 50mm Anterior Sacral Plate |
| 00840311233120 | 48mm Anterior Sacral Plate |
| 00840311233113 | 46mm Anterior Sacral Plate |
| 00840311233106 | 44mm Anterior Sacral Plate |
| 00840311233090 | 42mm Anterior Sacral Plate |
| 00840311233083 | 40mm Anterior Sacral Plate |
| 00840311233076 | 38mm Anterior Sacral Plate |
| 00840311233069 | 36mm Anterior Sacral Plate |
| 00840311233052 | 34mm Anterior Sacral Plate |
| 00840311232970 | 54mm Anterior Lumbar Plate |
| 00840311232963 | 52mm Anterior Lumbar Plate |
| 00840311232956 | 50mm Anterior Lumbar Plate |
| 00840311232949 | 48mm Anterior Lumbar Plate |
| 00840311232932 | 46mm Anterior Lumbar Plate |
| 00840311232925 | 44mm Anterior Lumbar Plate |
| 00840311232918 | 42mm Anterior Lumbar Plate |
| 00840311232901 | 40mm Anterior Lumbar Plate |
| 00840311232895 | 38mm Anterior Lumbar Plate |
| 00840311232888 | 36mm Anterior Lumbar Plate |
| 00840311232871 | 34mm Anterior Lumbar Plate |
| 00840311232772 | 6.5 X 40 Rescue Screw Assembly |
| 00840311232765 | 6.5 X 38 Rescue Screw Assembly |
| 00840311232758 | 6.5 X 36 Rescue Screw Assembly |
| 00840311232741 | 6.5 X 34 Rescue Screw Assembly |
| 00840311232734 | 6.5 X 32 Rescue Screw Assembly |
| 00840311232727 | 6.5 X 30 Rescue Screw Assembly |
| 00840311232710 | 6.5 X 28 Rescue Screw Assembly |
| 00840311232703 | 6.5 X 26 Rescue Screw Assembly |
| 00840311232697 | 6.5 X 24 Rescue Screw Assembly |
| 00840311232680 | 6.5 X 22 Rescue Screw Assembly |
| 00840311232673 | 6.0 X 40 Lumbar Screw Assembly |
| 00840311232666 | 6.0 X 38 Lumbar Screw Assembly |
| 00840311232659 | 6.0 X 36 Lumbar Screw Assembly |
| 00840311232642 | 6.0 X 34 Lumbar Screw Assembly |
| 00840311232635 | 6.0 X 32 Lumbar Screw Assembly |
| 00840311232628 | 6.0 X 30 Lumbar Screw Assembly |
| 00840311232611 | 6.0 X 28 Lumbar Screw Assembly |
| 00840311232604 | 6.0 X 26 Lumbar Screw Assembly |
| 00840311232598 | 6.0 X 24 Lumbar Screw Assembly |
| 00840311232581 | 6.0 X 22 Lumbar Screw Assembly |
| 00840311233243 | Contact ALP, Threaded Screw Inserter |
| 00840311233182 | Torque Limiting Handle, 1/4" Hex Drive |
| 00840311233175 | Tightener |
| 00840311233021 | RATCHETING T-HANDLE, 1/4" SQUARE DRIVE |
| 00840311232987 | Palm Handle, 1/4" Square Drive |
| 00840311232864 | Locker |
| 00840311232857 | Inserter |
| 00840311232840 | Holder |