Primary Device ID | 00850001740487 |
NIH Device Record Key | 1faeadef-1a29-4aa9-90d3-261686501cfc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Fortuna MIS eX-TAB Stabilization System |
Version Model Number | 211-75030-1 |
Company DUNS | 081363044 |
Company Name | OSSO SURGICAL LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
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 | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850001740487 [Primary] |
MNH | Orthosis, Spondylolisthesis Spinal Fixation |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00850001740487]
Moist Heat or Steam Sterilization
[00850001740487]
Moist Heat or Steam Sterilization
[00850001740487]
Moist Heat or Steam Sterilization
[00850001740487]
Moist Heat or Steam Sterilization
[00850001740487]
Moist Heat or Steam Sterilization
[00850001740487]
Moist Heat or Steam Sterilization
[00850001740487]
Moist Heat or Steam Sterilization
[00850001740487]
Moist Heat or Steam Sterilization
[00850001740487]
Moist Heat or Steam Sterilization
[00850001740487]
Moist Heat or Steam Sterilization
[00850001740487]
Moist Heat or Steam Sterilization
[00850001740487]
Moist Heat or Steam Sterilization
[00850001740487]
Moist Heat or Steam Sterilization
[00850001740487]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-09-24 |
Device Publish Date | 2020-09-16 |
00850001740685 | 5.5mm x 300mm Straight Rod, Bulleted |
00850001740678 | 5.5mm x 100mm Pre-Lordosed Rod, Bulleted |
00850001740661 | 5.5mm x 95mm Pre-Lordosed Rod, Bulleted |
00850001740654 | 5.5mm x 90mm Pre-Lordosed Rod, Bulleted |
00850001740647 | 5.5mm x 85mm Pre-Lordosed Rod, Bulleted |
00850001740630 | 5.5mm x 80mm Pre-Lordosed Rod, Bulleted |
00850001740623 | 5.5mm x 75mm Pre-Lordosed Rod, Bulleted |
00850001740616 | 5.5mm x 70mm Pre-Lordosed Rod, Bulleted |
00850001740609 | 5.5mm x 65mm Pre-Lordosed Rod, Bulleted |
00850001740593 | 5.5mm x 60mm Pre-Lordosed Rod, Bulleted |
00850001740586 | 5.5mm x 55mm Pre-Lordosed Rod, Bulleted |
00850001740579 | 5.5mm x 50mm Pre-Lordosed Rod, Bulleted |
00850001740562 | 5.5mm x 45mm Pre-Lordosed Rod, Bulleted |
00850001740555 | 5.5mm x 40mm Pre-Lordosed Rod, Bulleted |
00850001740548 | 5.5mm x 35mm Pre-Lordosed Rod, Bulleted |
00850001740531 | 7.5mm x 55mm MIS eX-TAB Screw, Cannulated |
00850001740524 | 7.5mm x 50mm MIS eX-TAB Screw, Cannulated |
00850001740517 | 7.5mm x 45mm MIS eX-TAB Screw, Cannulated |
00850001740500 | 7.5mm x 40mm MIS eX-TAB Screw, Cannulated |
00850001740494 | 7.5mm x 35mm MIS eX-TAB Screw, Cannulated |
00850001740487 | 7.5mm x 30mm MIS eX-TAB Screw, Cannulated |
00850001740470 | 6.5mm x 55mm MIS eX-TAB Screw, Cannulated |
00850001740463 | 6.5mm x 50mm MIS eX-TAB Screw, Cannulated |
00850001740456 | 6.5mm x 45mm MIS eX-TAB Screw, Cannulated |
00850001740449 | 6.5mm x 40mm MIS eX-TAB Screw, Cannulated |
00850001740432 | 6.5mm x 35mm MIS eX-TAB Screw, Cannulated |
00850001740425 | 6.5mm x 30mm MIS eX-TAB Screw, Cannulated |
00850001740418 | 5.5mm x 55mm MIS eX-TAB Screw, Cannulated |
00850001740401 | 5.5mm x 50mm MIS eX-TAB Screw, Cannulated |
00850001740395 | 5.5mm x 45mm MIS eX-TAB Screw, Cannulated |
00850001740388 | 5.5mm x 40mm MIS eX-TAB Screw, Cannulated |
00850001740371 | 5.5mm x 35mm MIS eX-TAB Screw, Cannulated |
00850001740364 | 5.5mm x 30mm MIS eX-TAB Screw, Cannulated |
00850001740814 | 4.5mm x 50mm MIS eX-TAB Screw, Cannulated |
00850001740807 | 4.5mm x 45mm MIS eX-TAB Screw, Cannulated |
00850001740791 | 4.5mm x 40mm MIS eX-TAB Screw, Cannulated |
00850001740784 | 4.5mm x 35mm MIS eX-TAB Screw, Cannulated |
00850001740777 | 5.5mm x 110mm Pre-Lordosed Rod, Bulleted |
00850001740821 | 5.5mm x 140mm Pre-Lordosed Rod, Bulleted |