Fortuna MIS eX-TAB Stabilization System

GUDID 00850001740807

4.5mm x 45mm MIS eX-TAB Screw, Cannulated

OSSO SURGICAL LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00850001740807
• NIH Device Record Key: 06d24b1f-ac90-4c04-a0cc-c16de1d761cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fortuna MIS eX-TAB Stabilization System
• Version Model Number: 211-45045-1
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00850001740807 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162576

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00850001740807]

Moist Heat or Steam Sterilization

[00850001740807]

Moist Heat or Steam Sterilization

[00850001740807]

Moist Heat or Steam Sterilization

[00850001740807]

Moist Heat or Steam Sterilization

[00850001740807]

Moist Heat or Steam Sterilization

[00850001740807]

Moist Heat or Steam Sterilization

[00850001740807]

Moist Heat or Steam Sterilization

[00850001740807]

Moist Heat or Steam Sterilization

[00850001740807]

Moist Heat or Steam Sterilization

[00850001740807]

Moist Heat or Steam Sterilization

[00850001740807]

Moist Heat or Steam Sterilization

[00850001740807]

Moist Heat or Steam Sterilization

[00850001740807]

Moist Heat or Steam Sterilization

[00850001740807]

Moist Heat or Steam Sterilization

[00850001740807]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-03
• Device Publish Date: 2021-04-23

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

• 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