NexGen Anterior Cervical Plate System 65-CA-1014

GUDID 00840019933131

Anterior Cervical Plate 1 Level - 14mm

PRECISION SPINE, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00840019933131
• NIH Device Record Key: 34585b7a-b80d-4e82-b725-5a9b3ac2fae0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NexGen Anterior Cervical Plate System
• Version Model Number: 65-CA-1014
• Catalog Number: 65-CA-1014
• Company DUNS: 079398589
• Company Name: PRECISION SPINE, INC.
• Device Count: 1
• DM Exempt: true
• 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	00840019933131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192494

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00840019933131]

Moist Heat or Steam Sterilization

[00840019933131]

Moist Heat or Steam Sterilization

[00840019933131]

Moist Heat or Steam Sterilization

[00840019933131]

Moist Heat or Steam Sterilization

[00840019933131]

Moist Heat or Steam Sterilization

[00840019933131]

Moist Heat or Steam Sterilization

[00840019933131]

Moist Heat or Steam Sterilization

[00840019933131]

Moist Heat or Steam Sterilization

[00840019933131]

Moist Heat or Steam Sterilization

[00840019933131]

Moist Heat or Steam Sterilization

[00840019933131]

Moist Heat or Steam Sterilization

[00840019933131]

Moist Heat or Steam Sterilization

[00840019933131]

Moist Heat or Steam Sterilization

[00840019933131]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-17
• Device Publish Date: 2020-02-07

On-Brand Devices [NexGen Anterior Cervical Plate System]

• 00840019936071: Anterior Cervical Plate 4 Level - 64mm
• 00840019936064: Anterior Cervical Plate 4 Level - 60mm
• 00840019936057: Anterior Cervical Plate 3 Level - 67mm
• 00840019936040: Anterior Cervical Plate 3 Level - 64mm
• 00840019936033: Anterior Cervical Plate 3 Level - 61mm
• 00840019936026: Anterior Cervical Plate 3 Level - 58mm
• 00840019933360: Anterior Cervical Plate 3 Level - 55mm
• 00840019933353: Anterior Cervical Plate 3 Level - 52mm
• 00840019933346: Anterior Cervical Plate 3 Level - 49mm
• 00840019933339: Anterior Cervical Plate 3 Level - 46mm
• 00840019933322: Anterior Cervical Plate 3 Level - 43mm
• 00840019933315: Anterior Cervical Plate 2 Level - 46mm
• 00840019933308: Anterior Cervical Plate 2 Level - 44mm
• 00840019933292: Anterior Cervical Plate 2 Level - 42mm
• 00840019933285: Anterior Cervical Plate 2 Level - 40mm
• 00840019933278: Anterior Cervical Plate 2 Level - 38mm
• 00840019933261: Anterior Cervical Plate 2 Level - 36mm
• 00840019933254: Anterior Cervical Plate 2 Level - 34mm
• 00840019933247: Anterior Cervical Plate 2 Level - 32mm
• 00840019933230: Anterior Cervical Plate 2 Level - 30mm
• 00840019933223: Anterior Cervical Plate 2 Level - 28mm
• 00840019933216: Anterior Cervical Plate 2 Level - 26mm
• 00840019933209: Anterior Cervical Plate 2 Level - 24mm
• 00840019933193: Anterior Cervical Plate 1 Level - 26mm
• 00840019933179: Anterior Cervical Plate 1 Level - 22mm
• 00840019933162: Anterior Cervical Plate 1 Level - 20mm
• 00840019933155: Anterior Cervical Plate 1 Level - 18mm
• 00840019933148: Anterior Cervical Plate 1 Level - 16mm
• 00840019933131: Anterior Cervical Plate 1 Level - 14mm
• 00840019933124: Anterior Cervical Plate 1 Level - 12mm
• 00840019933117: Anterior Cervical Plate 1 Level - 10mm
• 00840019933100: Self-Tapping Fixed Screw - 4.5mm x 18mm
• 00840019933094: Self-Tapping Fixed Screw - 4.5mm x 16mm
• 00840019933087: Self-Tapping Fixed Screw - 4.5mm x 14mm
• 00840019933070: Self-Tapping Fixed Screw - 4.5mm x 12mm
• 00840019933063: Self-Tapping Fixed Screw - 4.5mm x 10mm
• 00840019933056: Self-Tapping Variable Screw - 4.5mm x 18mm
• 00840019933049: Self-Tapping Variable Screw - 4.5mm x 16mm
• 00840019933032: Self-Tapping Variable Screw - 4.5mm x 14mm
• 00840019933025: Self-Tapping Variable Screw - 4.5mm x 12mm
• 00840019933018: Self-Tapping Variable Screw - 4.5mm x 10mm
• 00840019933001: Self-Drilling Fixed Screw - 4.5mm x 18mm
• 00840019932998: Self-Drilling Fixed Screw - 4.5mm x 16mm
• 00840019932981: Self-Drilling Fixed Screw - 4.5mm x 14mm
• 00840019932974: Self-Drilling Fixed Screw - 4.5mm x 12mm
• 00840019932967: Self-Drilling Fixed Screw - 4.5mm x 10mm
• 00840019932950: Self-Drilling Variable Screw - 4.5mm x 18mm
• 00840019932943: Self-Drilling Variable Screw - 4.5mm x 16mm
• 00840019932936: Self-Drilling Variable Screw - 4.5mm x 14mm
• 00840019932929: Self-Drilling Variable Screw - 4.5mm x 12mm