| Primary Device ID | M7408608005 |
| NIH Device Record Key | 2b800ccc-e9e9-4eae-b5ad-34e5e695ba49 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Duo Lumbar Interbody Fusion System |
| Version Model Number | 86-08-17-10 |
| Catalog Number | 860-8005 |
| Company DUNS | 033014361 |
| Company Name | SPINEOLOGY INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | +1(651)256-8500 |
| info@spineology.com |
| Height | 10 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M7408608005 [Primary] |
| MAX | Intervertebral fusion device with bone graft, lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M7408608005]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-05-13 |
| Device Publish Date | 2019-05-03 |
| M7401001030 | Duo Trial, 16mm, 8° |
| M7401001029 | Duo Trial, 14mm, 8° |
| M7401001028 | Duo Trial, 12mm, 8° |
| M7401001027 | Duo Trial, 10mm, 8° |
| M7408608110 | Duo LU Angled Trial, 14mm, 15° |
| M7408608109 | Duo LU Angled Trial, 12mm, 15° |
| M7408608103 | Duo LU Angled Trial, 16mm, 8° |
| M7408608102 | Duo LU Angled Trial, 14mm, 8° |
| M7408608101 | Duo LU Angled Trial, 12mm, 8° |
| M7408608100 | Duo LU Angled Trial, 10mm, 8° |
| M7408608008 | Duo Angled Trial, 16mm, 0° |
| M7408608007 | Duo Angled Trial, 14mm, 0° |
| M7408608006 | Duo Angled Trial, 12mm, 0° |
| M7408608005 | Duo Angled Trial, 10mm, 0° |
| M7408608004 | Duo Angled Trial, 8mm, 0° |
| M7408600519 | Duo Angled Inserter Fork |
| M7408600515 | Duo Angled Access Inserter |
| M7401001113 | Duo Angled Inserter Fork |
| M7401001112 | Duo Straight Inserter Fork |