NexGen Anterior Cervical Plate System 65-BK-0206

GUDID 00840019942928

Slimplicity HP 5 Level Plate Kit

PRECISION SPINE, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00840019942928
• NIH Device Record Key: acd21634-5fdf-4c4c-93e0-057afad2f825
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NexGen Anterior Cervical Plate System
• Version Model Number: 65-BK-0206
• Catalog Number: 65-BK-0206
• 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: false
• Lot Batch: false
• Serial Number: true
• 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	00840019942928 [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

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

[00840019942928]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-18
• Device Publish Date: 2021-06-10

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