Facet Fixx™ Facet Screw System

GUDID 00889929001387

Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 50mm

NEXXT SPINE, LLC

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00889929001387
• NIH Device Record Key: d007b4fc-86e0-4348-a3c1-10f863efdd44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Facet Fixx™ Facet Screw System
• Version Model Number: 14-12-5050
• Company DUNS: 003489810
• Company Name: NEXXT SPINE, 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com

Device Dimensions

• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889929001387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131417

FDA Product Code

• MRW: System, Facet Screw Spinal Device

Sterilization

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

[00889929001387]

Moist Heat or Steam Sterilization

[00889929001387]

Moist Heat or Steam Sterilization

[00889929001387]

Moist Heat or Steam Sterilization

[00889929001387]

Moist Heat or Steam Sterilization

[00889929001387]

Moist Heat or Steam Sterilization

[00889929001387]

Moist Heat or Steam Sterilization

[00889929001387]

Moist Heat or Steam Sterilization

[00889929001387]

Moist Heat or Steam Sterilization

[00889929001387]

Moist Heat or Steam Sterilization

[00889929001387]

Moist Heat or Steam Sterilization

[00889929001387]

Moist Heat or Steam Sterilization

[00889929001387]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-08-02
• Device Publish Date: 2015-07-23

On-Brand Devices [Facet Fixx™ Facet Screw System]

• 00889929011614: Facet Fixx Case
• 00889929011607: Facet Fixx Case
• 00889929011591: Facet Fixx Translaminar Caddy, 5.0mm
• 00889929011584: Facet Fixx Translaminar Caddy, 4.5mm
• 00889929011577: Facet Fixx Transfacet Caddy, 5.0mm
• 00889929011560: Facet Fixx Transfacet Caddy, 4.5mm
• 00889929024966: Facet Fixx, Screw, Full Thread, No Washer, Ø6.0 x 40mm
• 00889929024959: Facet Fixx, Screw, Full Thread, No Washer, Ø5.5 x 40mm
• 00889929024942: Facet Fixx, Screw, Full Thread, Ø6.0 x 40mm
• 00889929024935: Facet Fixx, Screw, Full Thread, Ø5.5 x 40mm
• 00889929024928: Facet Fixx, Screw, Partial Thread, Ø6.0 x 40mm
• 00889929024911: Facet Fixx, Screw, Partial Thread, Ø5.5 x 40mm
• 00889929019740: TransLaminar Screw, Partial Thread, Ø6.0 x 40mm
• 00889929019733: TransLaminar Screw, Partial Thread, Ø5.5 x 40mm
• 00889929019726: TransLaminar Screw, Partial Thread, Ø5.0 x 40mm
• 00889929019719: TransLaminar Screw, Partial Thread, Ø4.5 x 40mm
• 00889929019702: TransLaminar Screw, Partial Thread, Ø4.5 x 30mm
• 00889929019696: TransLaminar Screw, Partial Thread, Ø4.5 x 25mm
• 00889929019689: TransLaminar Screw, Partial Thread, Ø4.5 x 20mm
• 00889929001400: Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 60mm
• 00889929001394: Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 55mm
• 00889929001387: Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 50mm
• 00889929001370: Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 47.5mm
• 00889929001363: Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 45mm
• 00889929001356: Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 42.5mm
• 00889929001349: Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 40mm
• 00889929001332: Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 35mm
• 00889929001325: Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 32.5mm
• 00889929001318: Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 30mm
• 00889929001301: Facet Fixx, Screw, Full Thread, No Washer, Ø5.5 x 27.5mm
• 00889929001295: Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 25mm
• 00889929001288: Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 20mm
• 00889929001271: Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 60mm
• 00889929001264: Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 55mm
• 00889929001257: Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 50mm
• 00889929001240: Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 47.5mm
• 00889929001233: Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 45mm
• 00889929001226: Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 42.5mm
• 00889929001219: Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 40mm
• 00889929001202: Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 35mm
• 00889929001196: Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 32.5mm
• 00889929001189: Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 30mm
• 00889929001172: Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 27.5mm
• 00889929001165: Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 25mm
• 00889929001158: Facet Fixx, Screw, Full Thread, No Washer, Ø4.5 x 20mm
• 00889929001127: Facet Fixx, Screw, Full Thread, Ø5.0 x 50mm
• 00889929001110: Facet Fixx, Screw, Full Thread, Ø5.0 x 47.5mm
• 00889929001103: Facet Fixx, Screw, Full Thread, Ø5.0 x 45mm
• 00889929001097: Facet Fixx, Screw, Full Thread, Ø5.0 x 42.5mm
• 00889929001080: Facet Fixx, Screw, Full Thread, Ø5.0 x 40mm