| Primary Device ID | M7406401005 |
| NIH Device Record Key | 94ca73e0-b806-4b35-91da-a763e72b40e7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fortress Set Screw w/ Pedicle Screw |
| Version Model Number | 10-10-48-X |
| Catalog Number | 640-1005 |
| 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 | M7406401005 [Primary] |
| NKB | Orthosis, spinal pedicle fixation, for degenerative disc disease |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M7406401005]
Ethylene Oxide
[M7406401005]
Ethylene Oxide
[M7406401005]
Ethylene Oxide
[M7406401005]
Ethylene Oxide
[M7406401005]
Ethylene Oxide
[M7406401005]
Ethylene Oxide
[M7406401005]
Ethylene Oxide
[M7406401005]
Ethylene Oxide
[M7406401005]
Ethylene Oxide
[M7406401005]
Ethylene Oxide
[M7406401005]
Ethylene Oxide
[M7406401005]
Ethylene Oxide
[M7406401005]
Ethylene Oxide
[M7406401005]
Ethylene Oxide
[M7406401005]
Ethylene Oxide
[M7406401005]
Ethylene Oxide
[M7406401005]
Ethylene Oxide
[M7406401005]
Ethylene Oxide
[M7406401005]
Ethylene Oxide
[M7406401005]
Ethylene Oxide
[M7406401005]
Ethylene Oxide
[M7406401005]
Ethylene Oxide
[M7406401005]
Ethylene Oxide
[M7406401005]
Ethylene Oxide
[M7406401005]
Ethylene Oxide
[M7406401005]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-07-22 |
| Device Publish Date | 2014-12-05 |
| M7406401017 | Pedicle Screw & Set Screw |
| M7406401005 | Pedicle Screw & Set Screw |