Fortex Pedicle Screw System

GUDID M697X06447540C1

Assembly, Fortex, 4.75 x 40 Cannulated Mini Reduction Screw

Xtant Medical Holdings, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: M697X06447540C1
• NIH Device Record Key: 02baaeb5-4f9c-43d8-bad8-37bc8d748271
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fortex Pedicle Screw System
• Version Model Number: X064-47540C
• Company DUNS: 081224143
• Company Name: Xtant Medical Holdings, Inc.
• Device Count: 1
• DM Exempt: true
• 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

Customer Support Contacts

• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com

Device Dimensions

• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 4.75 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M697X06447540C1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090224

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

[M697X06447540C1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-06-03
• Device Publish Date: 2015-10-26

On-Brand Devices [Fortex Pedicle Screw System]

• M697X07707201: CoCr, 5.5mm Dia Bar X 500mm w/End stop
• M697X07707191: CoCr, 5.5mm Dia Bar X 300mm w/End stop
• M697X07707181: CoCr, 5.5mm Dia Bar X 200mm w/End stop
• M697X07707171: CoCr, 5.5mm Dia Bar X 180mm w/End stop
• M697X07707161: CoCr, 5.5mm Dia Bar X 160mm w/End stop
• M697X07707151: CoCr, 5.5mm Dia Bar X 140mm w/End stop
• M697X07707141: CoCr, 5.5mm Dia Bar X 120mm w/End stop
• M697X07707131: CoCr, 5.5mm Dia Bar X 100mm w/End stop
• M697X07707121: CoCr, 5.5mm Dia Bar X 95mm w/End stop
• M697X07707111: CoCr, 5.5mm Dia Bar X 90mm w/End stop
• M697X07707101: CoCr, 5.5mm Dia Bar X 85mm w/End stop
• M697X07707091: CoCr, 5.5mm Dia Bar X 80mm w/End stop
• M697X07707081: CoCr, 5.5mm Dia Bar X 75mm w/End stop
• M697X07707071: CoCr, 5.5mm Dia Bar X 70mm w/End stop
• M697X07707061: CoCr, 5.5mm Dia Bar X 65mm w/End stop
• M697X07707051: CoCr, 5.5mm Dia Bar X 60mm w/End stop
• M697X07707041: CoCr, 5.5mm Dia Bar X 55mm w/End stop
• M697X07707031: CoCr, 5.5mm Dia Bar X 50mm w/End stop
• M697X07707021: CoCr, 5.5mm Dia Bar X 45mm w/End stop
• M697X07707011: CoCr, 5.5mm Dia Bar X 40mm w/End stop
• M697X07707001: CoCr, 5.5mm Dia Bar X 35mm w/End stop
• M697X07706191: CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 160mm
• M697X07706181: CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 150mm
• M697X07706171: CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 140mm
• M697X07706161: CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 130mm
• M697X07706151: CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 120mm
• M697X07706141: CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 110mm
• M697X07706131: CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 100mm
• M697X07706121: CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 95mm
• M697X07706111: CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 90mm
• M697X07706101: CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 85mm
• M697X07706091: CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 80mm
• M697X07706081: CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 75mm
• M697X07706071: CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 70mm
• M697X07706061: CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 65mm
• M697X07706051: CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 60mm
• M697X07706041: CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 55mm
• M697X07706031: CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 50mm
• M697X07706021: CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 45mm
• M697X07706011: CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 40mm
• M697X07706001: CoCr, Continuous Radius Rods, 5.5mm Dia Bar X 35mm
• M697X07705191: CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 300mm
• M697X07705181: CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 200mm
• M697X07705171: CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 180mm
• M697X07705161: CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 160mm
• M697X07705151: CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 140mm
• M697X07705141: CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 120mm
• M697X07705131: CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 100mm
• M697X07705121: CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 95mm
• M697X07705111: CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 90mm