Fortuna MIS eX-TAB Stabilization System

GUDID 00850001740814

4.5mm x 50mm MIS eX-TAB Screw, Cannulated

OSSO SURGICAL LLC

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00850001740814
NIH Device Record Key41b9b6cf-8fee-4c77-9904-e92cb34ba40b
Commercial Distribution StatusIn Commercial Distribution
Brand NameFortuna MIS eX-TAB Stabilization System
Version Model Number211-45050-1
Company DUNS081363044
Company NameOSSO SURGICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850001740814 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850001740814]

Moist Heat or Steam Sterilization


[00850001740814]

Moist Heat or Steam Sterilization


[00850001740814]

Moist Heat or Steam Sterilization


[00850001740814]

Moist Heat or Steam Sterilization


[00850001740814]

Moist Heat or Steam Sterilization


[00850001740814]

Moist Heat or Steam Sterilization


[00850001740814]

Moist Heat or Steam Sterilization


[00850001740814]

Moist Heat or Steam Sterilization


[00850001740814]

Moist Heat or Steam Sterilization


[00850001740814]

Moist Heat or Steam Sterilization


[00850001740814]

Moist Heat or Steam Sterilization


[00850001740814]

Moist Heat or Steam Sterilization


[00850001740814]

Moist Heat or Steam Sterilization


[00850001740814]

Moist Heat or Steam Sterilization


[00850001740814]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-03
Device Publish Date2021-04-23

On-Brand Devices [Fortuna MIS eX-TAB Stabilization System]

008500017406855.5mm x 300mm Straight Rod, Bulleted
008500017406785.5mm x 100mm Pre-Lordosed Rod, Bulleted
008500017406615.5mm x 95mm Pre-Lordosed Rod, Bulleted
008500017406545.5mm x 90mm Pre-Lordosed Rod, Bulleted
008500017406475.5mm x 85mm Pre-Lordosed Rod, Bulleted
008500017406305.5mm x 80mm Pre-Lordosed Rod, Bulleted
008500017406235.5mm x 75mm Pre-Lordosed Rod, Bulleted
008500017406165.5mm x 70mm Pre-Lordosed Rod, Bulleted
008500017406095.5mm x 65mm Pre-Lordosed Rod, Bulleted
008500017405935.5mm x 60mm Pre-Lordosed Rod, Bulleted
008500017405865.5mm x 55mm Pre-Lordosed Rod, Bulleted
008500017405795.5mm x 50mm Pre-Lordosed Rod, Bulleted
008500017405625.5mm x 45mm Pre-Lordosed Rod, Bulleted
008500017405555.5mm x 40mm Pre-Lordosed Rod, Bulleted
008500017405485.5mm x 35mm Pre-Lordosed Rod, Bulleted
008500017405317.5mm x 55mm MIS eX-TAB Screw, Cannulated
008500017405247.5mm x 50mm MIS eX-TAB Screw, Cannulated
008500017405177.5mm x 45mm MIS eX-TAB Screw, Cannulated
008500017405007.5mm x 40mm MIS eX-TAB Screw, Cannulated
008500017404947.5mm x 35mm MIS eX-TAB Screw, Cannulated
008500017404877.5mm x 30mm MIS eX-TAB Screw, Cannulated
008500017404706.5mm x 55mm MIS eX-TAB Screw, Cannulated
008500017404636.5mm x 50mm MIS eX-TAB Screw, Cannulated
008500017404566.5mm x 45mm MIS eX-TAB Screw, Cannulated
008500017404496.5mm x 40mm MIS eX-TAB Screw, Cannulated
008500017404326.5mm x 35mm MIS eX-TAB Screw, Cannulated
008500017404256.5mm x 30mm MIS eX-TAB Screw, Cannulated
008500017404185.5mm x 55mm MIS eX-TAB Screw, Cannulated
008500017404015.5mm x 50mm MIS eX-TAB Screw, Cannulated
008500017403955.5mm x 45mm MIS eX-TAB Screw, Cannulated
008500017403885.5mm x 40mm MIS eX-TAB Screw, Cannulated
008500017403715.5mm x 35mm MIS eX-TAB Screw, Cannulated
008500017403645.5mm x 30mm MIS eX-TAB Screw, Cannulated
008500017408144.5mm x 50mm MIS eX-TAB Screw, Cannulated
008500017408074.5mm x 45mm MIS eX-TAB Screw, Cannulated
008500017407914.5mm x 40mm MIS eX-TAB Screw, Cannulated
008500017407844.5mm x 35mm MIS eX-TAB Screw, Cannulated
008500017407775.5mm x 110mm Pre-Lordosed Rod, Bulleted

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