Nex-D2

GUDID 00840314112798

NEXT ORTHOSURGICAL, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840314112798
• NIH Device Record Key: c34f29c3-cb32-4199-9859-2fdcdcf13c00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nex-D2
• Version Model Number: CBAAJ-78030
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840314112798 [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

[00840314112798]

Moist Heat or Steam Sterilization

[00840314112798]

Moist Heat or Steam Sterilization

[00840314112798]

Moist Heat or Steam Sterilization

[00840314112798]

Moist Heat or Steam Sterilization

[00840314112798]

Moist Heat or Steam Sterilization

[00840314112798]

Moist Heat or Steam Sterilization

[00840314112798]

Moist Heat or Steam Sterilization

[00840314112798]

Moist Heat or Steam Sterilization

[00840314112798]

Moist Heat or Steam Sterilization

[00840314112798]

Moist Heat or Steam Sterilization

[00840314112798]

Moist Heat or Steam Sterilization

[00840314112798]

Moist Heat or Steam Sterilization

[00840314112798]

Moist Heat or Steam Sterilization

[00840314112798]

Moist Heat or Steam Sterilization

[00840314112798]

Moist Heat or Steam Sterilization

[00840314112798]

Moist Heat or Steam Sterilization

[00840314112798]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-28
• Device Publish Date: 2024-08-20

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
• 00840314112866: CBAAJ-78065
• 00840314112859: CBAAJ-78060
• 00840314112842: CBAAJ-78055
• 00840314112835: CBAAJ-78050
• 00840314112828: CBAAJ-78045
• 00840314112811: CBAAJ-78040
• 00840314112804: CBAAJ-78035
• 00840314112798: CBAAJ-78030
• 00840314112781: CBAAJ-78025
• 00840314112774: CBAAJ-78020
• 00840314112767: CBAAJ-70150
• 00840314112750: CBAAJ-70140
• 00840314112743: CBAAJ-70130
• 00840314112736: CBAAJ-70125
• 00840314112729: CBAAJ-70120
• 00840314112712: CBAAJ-70115
• 00840314112705: K141291
• 00840314112699: CBAAJ-70105
• 00840314112682: CBAAJ-70100
• 00840314112675: CBAAJ-70095
• 00840314112668: CBAAJ-70090
• 00840314112651: CBAAJ-70085
• 00840314112644: CBAAJ-70080
• 00840314112637: CBAAJ-70075
• 00840314112620: CBAAJ-70070
• 00840314112613: CBAAJ-70065
• 00840314112606: CBAAJ-70060
• 00840314112590: CBAAJ-70055
• 00840314112583: CBAAJ-70050
• 00840314112576: CBAAJ-70045
• 00840314112569: CBAAJ-70040
• 00840314112552: CBAAJ-70035
• 00840314112545: CBAAJ-70030
• 00840314112538: CBAAJ-70025
• 00840314112521: CBAAJ-70020
• 00840314112514: CBAAJ-60150
• 00840314112507: CBAAJ-60140
• 00840314112491: CBAAJ-60130
• 00840314112484: CBAAJ-60125
• 00840314112477: CBAAJ-60120
• 00840314112460: CBAAJ-60115