| Primary Device ID | M7405300007 |
| NIH Device Record Key | 5ae0d5b8-17a0-4baa-a186-d780dfb55c4d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Threshold Set Screww/ Pedicle Screw |
| Version Model Number | 10-10-09-X |
| Catalog Number | 530-0007 |
| Company DUNS | 033014361 |
| Company Name | SPINEOLOGY INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com | |
| Phone | +1(651)256-8500 |
| info@spineology.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M7405300007 [Primary] |
| MNH | Orthosis, spondylolisthesis spinal fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M7405300007]
Ethylene Oxide
[M7405300007]
Ethylene Oxide
[M7405300007]
Ethylene Oxide
[M7405300007]
Ethylene Oxide
[M7405300007]
Ethylene Oxide
[M7405300007]
Ethylene Oxide
[M7405300007]
Ethylene Oxide
[M7405300007]
Ethylene Oxide
[M7405300007]
Ethylene Oxide
[M7405300007]
Ethylene Oxide
[M7405300007]
Ethylene Oxide
[M7405300007]
Ethylene Oxide
[M7405300007]
Ethylene Oxide
[M7405300007]
Ethylene Oxide
[M7405300007]
Ethylene Oxide
[M7405300007]
Ethylene Oxide
[M7405300007]
Ethylene Oxide
[M7405300007]
Ethylene Oxide
[M7405300007]
Ethylene Oxide
[M7405300007]
Ethylene Oxide
[M7405300007]
Ethylene Oxide
[M7405300007]
Ethylene Oxide
[M7405300007]
Ethylene Oxide
[M7405300007]
Ethylene Oxide
[M7405300007]
Ethylene Oxide
[M7405300007]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-07-23 |
| Device Publish Date | 2015-01-09 |
| M7407408599 - Fortress Pedicale Screw | 2024-11-07 Pedicle Screw |
| M7401001293 - Rampart One Lumbar Interbody Fusion System | 2024-09-16 Straight Awl |
| M7404300038 - CAPTURE Facet Screw Set System | 2024-09-11 Palm Ratchet Handle |
| M7404600001 - Rampart One Lumbar Interbody Fusion System | 2024-09-11 Oblique Inserter |
| M7404900012 - Rampart One Lumbar Interbody Fusion System | 2024-09-11 T20 Hexalobe Ball Driver |
| M7404901824 - Rampart One Lumbar Interbody Fusion System | 2024-09-11 Inserter Driver |
| M7404910003 - Ramport One Pedicular Fixation System | 2024-09-11 Distractor Inserter |
| M7404910004 - Ramport One Pedicular Fixation System | 2024-09-11 Inserter Shaft |