Facet Fixx™ Facet Screw System

GUDID 00889929011584

Facet Fixx Translaminar Caddy, 4.5mm

NEXXT SPINE, LLC

Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable

• Primary Device ID: 00889929011584
• NIH Device Record Key: 32944565-8857-4552-90f9-b07096a52c4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Facet Fixx™ Facet Screw System
• Version Model Number: C14-01-04
• 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: false
• 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
• 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
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889929011584 [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

[00889929011584]

Moist Heat or Steam Sterilization

[00889929011584]

Moist Heat or Steam Sterilization

[00889929011584]

Moist Heat or Steam Sterilization

[00889929011584]

Moist Heat or Steam Sterilization

[00889929011584]

Moist Heat or Steam Sterilization

[00889929011584]

Moist Heat or Steam Sterilization

[00889929011584]

Moist Heat or Steam Sterilization

[00889929011584]

Moist Heat or Steam Sterilization

[00889929011584]

Moist Heat or Steam Sterilization

[00889929011584]

Moist Heat or Steam Sterilization

[00889929011584]

Moist Heat or Steam Sterilization

[00889929011584]

Moist Heat or Steam Sterilization

[00889929011584]

Moist Heat or Steam Sterilization

[00889929011584]

Moist Heat or Steam Sterilization

[00889929011584]

Moist Heat or Steam Sterilization

[00889929011584]

Moist Heat or Steam Sterilization

[00889929011584]

Moist Heat or Steam Sterilization

[00889929011584]

Moist Heat or Steam Sterilization

[00889929011584]

Moist Heat or Steam Sterilization

[00889929011584]

Moist Heat or Steam Sterilization

[00889929011584]

Moist Heat or Steam Sterilization

[00889929011584]

Moist Heat or Steam Sterilization

[00889929011584]

Moist Heat or Steam Sterilization

[00889929011584]

Moist Heat or Steam Sterilization

[00889929011584]

Moist Heat or Steam Sterilization

[00889929011584]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2021-07-08
• Device Publish Date: 2016-09-24

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