| Primary Device ID | 00850028694459 |
| NIH Device Record Key | 17efc453-20a2-40b8-895c-526d38d0570e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HOLO |
| Version Model Number | 154000111 |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850028694459 [Primary] |
| HWX | TAP, BONE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850028694459]
Moist Heat or Steam Sterilization
[00850028694459]
Moist Heat or Steam Sterilization
[00850028694459]
Moist Heat or Steam Sterilization
[00850028694459]
Moist Heat or Steam Sterilization
[00850028694459]
Moist Heat or Steam Sterilization
[00850028694459]
Moist Heat or Steam Sterilization
[00850028694459]
Moist Heat or Steam Sterilization
[00850028694459]
Moist Heat or Steam Sterilization
[00850028694459]
Moist Heat or Steam Sterilization
[00850028694459]
Moist Heat or Steam Sterilization
[00850028694459]
Moist Heat or Steam Sterilization
[00850028694459]
Moist Heat or Steam Sterilization
[00850028694459]
Moist Heat or Steam Sterilization
[00850028694459]
Moist Heat or Steam Sterilization
[00850028694459]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-17 |
| Device Publish Date | 2023-04-07 |
| 00850028694701 | HOLO SL Reduction Driver Lock Tube |
| 00850028694688 | HOLO Streamline Driver, Lock Tube |
| 00850028694671 | HOLO Streamline Driver, Open Cannulated |
| 00850028694664 | HOLO Streamline Driver, Solid |
| 00850028694633 | HOLO Patient Array |
| 00850028694626 | HOLO Pin Impact Cap |
| 00850028694619 | HOLO Iliac Pin, 200mm |
| 00850028694602 | HOLO Iliac Pin, 150mm |
| 00850028694596 | HOLO Iliac Pin, 100mm |
| 00850028694572 | HOLO Streamline Tap, Solid, 9.5 mm |
| 00850028694565 | HOLO Streamline Tap, Solid, 8.5 mm |
| 00850028694558 | HOLO Streamline Tap, Solid, 7.5 mm |
| 00850028694541 | HOLO Streamline Tap, Solid, 6.5 mm |
| 00850028694534 | HOLO Streamline Tap, Solid, 5.5 mm |
| 00850028694527 | HOLO Streamline Tap, Solid, 4.5 mm |
| 00850028694510 | HOLO Streamline Tap, Cann, 9.5 mm |
| 00850028694503 | HOLO Streamline Tap, Cann, 8.5 mm |
| 00850028694497 | HOLO Streamline Tap, Cann, 7.5 mm |
| 00850028694480 | HOLO Streamline Tap, Cann, 6.5 mm |
| 00850028694473 | HOLO Streamline Tap, Cann, 5.5 mm |
| 00850028694466 | HOLO Streamline Tap, Cann, 4.5 mm |
| 00850028694459 | HOLO Streamline Tap, Cann, 4.0 mm |
| 00850028694428 | HOLO Calibration Tube, Pedicle Prep Ins |
| 00850028694237 | HOLO AR Glasses |
| 00840311242894 | HOLO Fixed Handle, 1/4" Square |
| 00840311242689 | HOLO Calibration Tube, Screwdriver |
| 00840311236916 | HOLO Probe, Lenke, Iliac, Straight |
| 00840311233564 | HOLO Probe, Lenke, Thoracic, Straight |
| 00840311233557 | HOLO Probe, Lenke, Lumbar, Straight |
| 00810076560281 | HOLO Probe, Lenke, Iliac, Straight |
| 00850028694695 | HOLO Awl |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HOLO 98610707 not registered Live/Pending |
SHENZHEN FIRST UNION TECHNOLOGY CO., LTD. 2024-06-20 |
![]() HOLO 97927870 not registered Live/Pending |
Holo Surgical, Inc. 2023-05-09 |
![]() HOLO 97593482 not registered Live/Pending |
Holo, Inc. 2022-09-15 |
![]() HOLO 97412324 not registered Live/Pending |
Zeroharm science's USA LLC 2022-05-16 |
![]() HOLO 97275745 not registered Live/Pending |
Holo Health AB 2022-02-20 |
![]() HOLO 97275743 not registered Live/Pending |
Holo Health AB 2022-02-20 |
![]() HOLO 97275385 not registered Live/Pending |
Holo Health AB 2022-02-19 |
![]() HOLO 97275382 not registered Live/Pending |
Holo Health AB 2022-02-19 |
![]() HOLO 97275377 not registered Live/Pending |
Holo Health AB 2022-02-19 |
![]() HOLO 97275364 not registered Live/Pending |
Holo Health AB 2022-02-19 |
![]() HOLO 90764089 not registered Live/Pending |
Holo Surgical Inc. 2021-06-09 |
![]() HOLO 90708714 not registered Live/Pending |
Tzumi Electronics LLC 2021-05-13 |