Nex-D2 CBAJJ-40045

GUDID 00840314107848

UNIPLANAR SCREW, 4.0MM X 45MM

NEXT ORTHOSURGICAL, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840314107848
• NIH Device Record Key: 0bb5de03-ce2e-4733-8dcb-365f8a7b1567
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nex-D2
• Version Model Number: CBAJJ-40045
• Catalog Number: CBAJJ-40045
• Company DUNS: 046767258
• Company Name: NEXT ORTHOSURGICAL, INC.
• 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

Customer Support Contacts

• Phone: 760-295-3600
• Email: Info@nextorthosurgical.com

Device Dimensions

• Length: 45 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840314107848 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141291

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[00840314107848]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-07
• Device Publish Date: 2020-04-29

On-Brand Devices [Nex-D2]

• 00840314116567: SET SCREW, T-30 HEXALOBE
• 00840314155467: POLYAXIAL SCREW, LARGE OD, 8.0MM X 30MM
• 00840314139115: HIGH TOP UNIPLANAR SCREW, 4.0MM X 20MM
• 00840314116574: SET SCREW, CANNULATED, T-30 HEXALOBE
• 00840314115560: CANNULATED POLYAXIAL SCREW, 5.0MM X 20MM
• 00840314114310: FIXED SCREW, 4.0MM X 20MM
• 00840314113085: HIGH TOP POLYAXIAL SCREW, 4.0MM X 30MM
• 00840314111814: POLYAXIAL SCREW, 4.0MM X 40MM
• 00840314107848: UNIPLANAR SCREW, 4.0MM X 45MM