| Primary Device ID | M7408606028 |
| NIH Device Record Key | 0a75ddef-092d-4d76-aa33-3551e7392831 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Duo Ti Expandable Interbody Fusion System |
| Version Model Number | 86-06-28 |
| Catalog Number | 860-6028 |
| Company DUNS | 033014361 |
| Company Name | SPINEOLOGY INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| 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 | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M7408606028 [Primary] |
| LXN | Probe, Test, Heart-Valve |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M7408606028]
Moist Heat or Steam Sterilization
[M7408606028]
Moist Heat or Steam Sterilization
[M7408606028]
Moist Heat or Steam Sterilization
[M7408606028]
Moist Heat or Steam Sterilization
[M7408606028]
Moist Heat or Steam Sterilization
[M7408606028]
Moist Heat or Steam Sterilization
[M7408606028]
Moist Heat or Steam Sterilization
[M7408606028]
Moist Heat or Steam Sterilization
[M7408606028]
Moist Heat or Steam Sterilization
[M7408606028]
Moist Heat or Steam Sterilization
[M7408606028]
Moist Heat or Steam Sterilization
[M7408606028]
Moist Heat or Steam Sterilization
[M7408606028]
Moist Heat or Steam Sterilization
[M7408606028]
Moist Heat or Steam Sterilization
[M7408606028]
Moist Heat or Steam Sterilization
[M7408606028]
Moist Heat or Steam Sterilization
[M7408606028]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-08 |
| Device Publish Date | 2023-12-29 |
| M7408610048 | Duo Ti Angled Trial, 16mm, 15° |
| M7408610047 | Duo Ti Angled Trial, 14mm, 15° |
| M7408610046 | Duo Ti Angled Trial, 12mm, 15° |
| M7408610045 | Duo Ti Angled Trial, 16mm, 8° |
| M7408610044 | Duo Ti Angled Trial, 14mm, 8° |
| M7408610043 | Duo Ti Angled Trial, 12mm, 8° |
| M7408610042 | Duo Ti Angled Trial, 10mm, 8° |
| M7408610041 | Duo Ti Angled Trial, 16mm, 0° |
| M7408610040 | Duo Ti Angled Trial, 14mm, 0° |
| M7408610039 | Duo Ti Angled Trial, 12mm, 0° |
| M7408610038 | Duo Ti Angled Trial, 10mm, 0° |
| M7408610037 | Duo Ti Angled Trial, 8mm, 0° |
| M7408610036 | Duo Ti Trial, 16mm, 15° |
| M7408610035 | Duo Ti Trial, 14mm, 15° |
| M7408610034 | Duo Ti Trial, 12mm, 15° |
| M7408610033 | Duo Ti Trial, 16mm, 8° |
| M7408610032 | Duo Ti Trial, 14mm, 8° |
| M7408610031 | Duo Ti Trial, 12mm, 8° |
| M7408610030 | Duo Ti Trial, 10mm, 8° |
| M7408610029 | Duo Ti Trial, 16mm, 0° |
| M7408610028 | Duo Ti Trial, 14mm, 0° |
| M7408610027 | Duo Ti Trial, 12mm, 0° |
| M7408610026 | Duo Ti Trial, 10mm, 0° |
| M7408610025 | Duo Ti Trial, 8mm, 0° |
| M7402976016 | Duo Ti, 60 x 16mm, 15° |
| M7402976014 | Duo Ti, 60 x 14mm, 15° |
| M7402976012 | Duo Ti, 60 x 12mm, 15° |
| M7402975516 | Duo Ti, 55 x 16mm, 15° |
| M7402975514 | Duo Ti, 55 x 14mm, 15° |
| M7402975512 | Duo Ti, 55 x 12mm, 15° |
| M7402975016 | Duo Ti, 50 x 16mm, 15° |
| M7402975014 | Duo Ti, 50 x 14mm, 15° |
| M7402975012 | Duo Ti, 50 x 12mm, 15° |
| M7402974516 | Duo Ti, 45 x 16mm, 15° |
| M7402974514 | Duo Ti, 45 x 14mm, 15° |
| M7402974512 | Duo Ti, 45 x 12mm, 15° |
| M7402966016 | Duo Ti, 60 x 16mm, 8° |
| M7402966014 | Duo Ti, 60 x 14mm, 8° |
| M7402966012 | Duo Ti, 60 x 12mm, 8° |
| M7402966010 | Duo Ti, 60 x 10mm, 8° |
| M7402965516 | Duo Ti, 55 x 16mm, 8° |
| M7402965514 | Duo Ti, 55 x 14mm, 8° |
| M7402965512 | Duo Ti, 55 x 12mm, 8° |
| M7402965510 | Duo Ti, 55 x 10mm, 8° |
| M7402965016 | Duo Ti, 50 x 16mm, 8° |
| M7402965014 | Duo Ti, 50 x 14mm, 8° |
| M7402965012 | Duo Ti, 50 x 12mm, 8° |
| M7402965010 | Duo Ti, 50 x 10mm, 8° |
| M7402964516 | Duo Ti, 45 x 16mm, 8° |
| M7402964514 | Duo Ti, 45 x 14mm, 8° |