Fortezza Spinal Stabilization System

GUDID 00850001740111

6.5mm x 55mm Multi-Axial Screw, Cannulated

OSSO SURGICAL LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00850001740111
• NIH Device Record Key: 4a6149bb-2b1f-4293-871c-9895904f5a18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fortezza Spinal Stabilization System
• Version Model Number: 111-65055-1
• 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	00850001740111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162576

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[00850001740111]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-24
• Device Publish Date: 2018-11-23

On-Brand Devices [Fortezza Spinal Stabilization System]

• 00850001740340: Set Screw
• 00850001740333: 5.5mm x 100mm Pre-Lordosed Rod
• 00850001740326: 5.5mm x 95mm Pre-Lordosed Rod
• 00850001740319: 5.5mm x 90mm Pre-Lordosed Rod
• 00850001740302: 5.5mm x 85mm Pre-Lordosed Rod
• 00850001740296: 5.5mm x 80mm Pre-Lordosed Rod
• 00850001740289: 5.5mm x 75mm Pre-Lordosed Rod
• 00850001740272: 5.5mm x 70mm Pre-Lordosed Rod
• 00850001740265: 5.5mm x 65mm Pre-Lordosed Rod
• 00850001740258: 5.5mm x 60mm Pre-Lordosed Rod
• 00850001740241: 5.5mm x 55mm Pre-Lordosed Rod
• 00850001740234: 5.5mm x 50mm Pre-Lordosed Rod
• 00850001740227: 5.5mm x 45mm Pre-Lordosed Rod
• 00850001740210: 5.5mm x 40mm Pre-Lordosed Rod
• 00850001740203: 5.5mm x 35mm Pre-Lordosed Rod
• 00850001740197: 8.5mm x 45mm Multi-Axial Screw, Cannulated
• 00850001740180: 8.5mm x 40mm Multi-Axial Screw, Cannulated
• 00850001740173: 7.5mm x 55mm Multi-Axial Screw, Cannulated
• 00850001740166: 7.5mm x 50mm Multi-Axial Screw, Cannulated
• 00850001740159: 7.5mm x 45mm Multi-Axial Screw, Cannulated
• 00850001740142: 7.5mm x 40mm Multi-Axial Screw, Cannulated
• 00850001740135: 7.5mm x 35mm Multi-Axial Screw, Cannulated
• 00850001740128: 7.5mm x 30mm Multi-Axial Screw, Cannulated
• 00850001740111: 6.5mm x 55mm Multi-Axial Screw, Cannulated
• 00850001740104: 6.5mm x 50mm Multi-Axial Screw, Cannulated
• 00850001740098: 6.5mm x 45mm Multi-Axial Screw, Cannulated
• 00850001740081: 6.5mm x 40mm Multi-Axial Screw, Cannulated
• 00850001740074: 6.5mm x 35mm Multi-Axial Screw, Cannulated
• 00850001740067: 6.5mm x 30mm Multi-Axial Screw, Cannulated
• 00850001740050: 5.5mm x 55mm Multi-Axial Screw, Cannulated
• 00850001740043: 5.5mm x 50mm Multi-Axial Screw, Cannulated
• 00850001740036: 5.5mm x 45mm Multi-Axial Screw, Cannulated
• 00850001740029: 5.5mm x 40mm Multi-Axial Screw, Cannulated
• 00850001740012: 5.5mm x 35mm Multi-Axial Screw, Cannulated
• 00850001740005: 5.5mm x 30mm Multi-Axial Screw, Cannulated
• 00850001740357: 8.5mm x 50mm Multi-Axial Screw, Cannulated