NEO Anterior Cervical Plate System

GUDID 00190837007850

Life Spine, Inc.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00190837007850
• NIH Device Record Key: e6baa4da-5855-43b4-a723-0713a848343a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEO Anterior Cervical Plate System
• Version Model Number: 106-046
• Company DUNS: 183641617
• Company Name: Life 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	00190837007850 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040844

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00190837007850]

Moist Heat or Steam Sterilization

[00190837007850]

Moist Heat or Steam Sterilization

[00190837007850]

Moist Heat or Steam Sterilization

[00190837007850]

Moist Heat or Steam Sterilization

[00190837007850]

Moist Heat or Steam Sterilization

[00190837007850]

Moist Heat or Steam Sterilization

[00190837007850]

Moist Heat or Steam Sterilization

[00190837007850]

Moist Heat or Steam Sterilization

[00190837007850]

Moist Heat or Steam Sterilization

[00190837007850]

Moist Heat or Steam Sterilization

[00190837007850]

Moist Heat or Steam Sterilization

[00190837007850]

Moist Heat or Steam Sterilization

[00190837007850]

Moist Heat or Steam Sterilization

[00190837007850]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-09

On-Brand Devices [NEO Anterior Cervical Plate System]

• 00190837008048: 112-110
• 00190837008031: 112-105
• 00190837008024: 112-100
• 00190837008017: 112-095
• 00190837008000: 110-090
• 00190837007997: 110-086
• 00190837007980: 110-082
• 00190837007973: 110-078
• 00190837007966: 110-074
• 00190837007959: 108-074
• 00190837007942: 108-070
• 00190837007935: 108-067
• 00190837007928: 108-064
• 00190837007911: 108-061
• 00190837007904: 108-058
• 00190837007898: 108-055
• 00190837007881: 108-052
• 00190837007874: 106-050
• 00190837007867: 106-048
• 00190837007850: 106-046
• 00190837007843: 106-044
• 00190837007836: 106-042
• 00190837007829: 106-040
• 00190837007812: 106-038
• 00190837007805: 106-036
• 00190837007799: 106-034
• 00190837007782: 104-034
• 00190837007775: 104-032
• 00190837007768: 104-030
• 00190837007751: 104-028
• 00190837007744: 104-026
• 00190837007737: 104-024
• 00190837007720: 104-022
• 00190837007713: 104-020