NEXXT MATRIXX® Stand Alone Cervical System

GUDID 00889929030479

SA Cervical Interbody, 14Dx16Wx10H

NEXXT SPINE, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: 00889929030479
• NIH Device Record Key: 882ecabf-38ff-4624-aa7f-13962d5a65d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEXXT MATRIXX® Stand Alone Cervical System
• Version Model Number: 52-1416-10-SP
• 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: true
• 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

Device Dimensions

• Angle: 6 degree
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 10 Millimeter
• Angle: 6 degree
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 10 Millimeter
• Angle: 6 degree
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 10 Millimeter
• Angle: 6 degree
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 10 Millimeter
• Angle: 6 degree
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 10 Millimeter
• Angle: 6 degree
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 10 Millimeter
• Angle: 6 degree
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 10 Millimeter
• Angle: 6 degree
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 10 Millimeter
• Angle: 6 degree
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 10 Millimeter
• Angle: 6 degree
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 10 Millimeter
• Angle: 6 degree
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 10 Millimeter
• Angle: 6 degree
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 10 Millimeter
• Angle: 6 degree
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 10 Millimeter
• Angle: 6 degree
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 10 Millimeter
• Angle: 6 degree
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 10 Millimeter
• Angle: 6 degree
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 10 Millimeter
• Angle: 6 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889929030479 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190546

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-28
• Device Publish Date: 2020-02-20

On-Brand Devices [NEXXT MATRIXX® Stand Alone Cervical System]

• 00889929033487: SA Cervical Assembly, Qty=1 14Dx16Wx8H Interbody and Qty=2 Ø3.5x14mm Screws
• 00889929033470: SA Cervical Assembly, Qty=1 14Dx16Wx7H Interbody and Qty=2 Ø3.5x14mm Screws
• 00889929033463: SA Cervical Assembly, Qty=1 14Dx16Wx6H Interbody and Qty=2 Ø3.5x14mm Screws
• 00889929033456: SA Cervical Assembly, Qty=1 14Dx16Wx5H Interbody and Qty=2 Ø3.5x14mm Screws
• 00889929033449: SA Cervical Assembly, Qty=1 12Dx14Wx12H Interbody and Qty=2 Ø3.5x12mm Screws
• 00889929033432: SA Cervical Assembly, Qty=1 12Dx14Wx11H Interbody and Qty=2 Ø3.5x12mm Screws
• 00889929033425: SA Cervical Assembly, Qty=1 12Dx14Wx10H Interbody and Qty=2 Ø3.5x12mm Screws
• 00889929033418: SA Cervical Assembly, Qty=1 12Dx14Wx9H Interbody and Qty=2 Ø3.5x12mm Screws
• 00889929033401: SA Cervical Assembly, Qty=1 12Dx14Wx8H Interbody and Qty=2 Ø3.5x12mm Screws
• 00889929033395: SA Cervical Assembly, Qty=1 12Dx14Wx7H Interbody and Qty=2 Ø3.5x12mm Screws
• 00889929033388: SA Cervical Assembly, Qty=1 12Dx14Wx6H Interbody and Qty=2 Ø3.5x12mm Screws
• 00889929033371: SA Cervical Assembly, Qty=1 12Dx14Wx5H Interbody and Qty=2 Ø3.5x12mm Screws
• 00889929033609: SA Cervical Assembly, Qty=1 16Dx18Wx12H Interbody and Qty=2 Ø3.5x16mm Screws
• 00889929033593: SA Cervical Assembly, Qty=1 16Dx18Wx11H Interbody and Qty=2 Ø3.5x16mm Screws
• 00889929033586: SA Cervical Assembly, Qty=1 16Dx18Wx10H Interbody and Qty=2 Ø3.5x16mm Screws
• 00889929033579: SA Cervical Assembly, Qty=1 16Dx18Wx9H Interbody and Qty=2 Ø3.5x16mm Screws
• 00889929033562: SA Cervical Assembly, Qty=1 16Dx18Wx8H Interbody and Qty=2 Ø3.5x16mm Screws
• 00889929033555: SA Cervical Assembly, Qty=1 16Dx18Wx7H Interbody and Qty=2 Ø3.5x16mm Screws
• 00889929033548: SA Cervical Assembly, Qty=1 16Dx18Wx6H Interbody and Qty=2 Ø3.5x16mm Screws
• 00889929033531: SA Cervical Assembly, Qty=1 16Dx18Wx5H Interbody and Qty=2 Ø3.5x16mm Screws
• 00889929033524: SA Cervical Assembly, Qty=1 14Dx16Wx12H Interbody and Qty=2 Ø3.5x14mm Screws
• 00889929033517: SA Cervical Assembly, Qty=1 14Dx16Wx11H Interbody and Qty=2 Ø3.5x14mm Screws
• 00889929033500: SA Cervical Assembly, Qty=1 14Dx16Wx10H Interbody and Qty=2 Ø3.5x14mm Screws
• 00889929033494: SA Cervical Assembly, Qty=1 14Dx16Wx9H Interbody and Qty=2 Ø3.5x14mm Screws
• 00889929033364: SA Cervical Screw, Ø4.0x18mm
• 00889929033357: SA Cervical Screw, Ø4.0x16mm
• 00889929033340: SA Cervical Screw, Ø4.0x14mm
• 00889929033333: SA Cervical Screw, Ø4.0x12mm
• 00889929033326: SA Cervical Screw, Ø3.5x18mm
• 00889929033319: SA Cervical Screw, Ø3.5x16mm
• 00889929033302: SA Cervical Screw, Ø3.5x14mm
• 00889929033296: SA Cervical Screw, Ø3.5x12mm
• 00889929034019: Fixed Angle Driver, Sleeve
• 00889929034507: SA Cervical U Joint Poly Angle, Screw Removal
• 00889929034491: SA Cervical U Joint Poly Angle, Awl
• 00889929034484: SA Cervical U Joint Poly Angle, Drill
• 00889929034477: SA Cervical U Joint Poly Angle, Driver
• 00889929034460: Sleeved Awl
• 00889929034613: SA Cervical, Inserter, Modular, Inner Shaft
• 00889929034606: SA Cervical Fixed Angle Driver Tip, Screw Removal Long
• 00889929034590: SA Cervical Fixed Angle Driver Tip, Screw Removal Short
• 00889929034583: SA Cervical Fixed Angle Driver Tip, Hexalobe Long
• 00889929034576: SA Cervical Fixed Angle Driver Tip, Hexalobe Short
• 00889929034569: SA Cervical Fixed Angle Driver Tip, Drill Long
• 00889929034552: SA Cervical Fixed Angle Driver Tip, Drill Short
• 00889929034545: SA Cervical Fixed Angle Driver, Handle Assembly
• 00889929034538: SA Cervical Fixed Angle Driver, Inner Shaft Assembly
• 00889929034521: SA Cervical Fixed Angle Driver, Outer Shaft Assembly
• 00889929034774: SA Cervical Fixed Angle Driver Tip, Awl Long
• 00889929034767: SA Cervical Fixed Angle Driver Tip, Awl Short