Primary Device ID | M7401001028 |
NIH Device Record Key | 6f650e84-2755-4390-8757-a9df5c38c839 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Duo Lumbar Interbody Fusion System |
Version Model Number | 101-56-02-12 |
Catalog Number | 100-1028 |
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 |
aadams@spineology.com |
Height | 12 Millimeter |
Height | 12 Millimeter |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M7401001028 [Primary] |
MAX | Intervertebral fusion device with bone graft, lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M7401001028]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-04-03 |
Device Publish Date | 2019-03-26 |
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 |