NEO SL Anterior Cervical Plate System

GUDID 00190837008338

Life Spine, Inc.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00190837008338
• NIH Device Record Key: e1bd4460-4e01-4064-a867-687e61074626
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEO SL Anterior Cervical Plate System
• Version Model Number: SL4-086
• 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	00190837008338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070285

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00190837008338]

Moist Heat or Steam Sterilization

[00190837008338]

Moist Heat or Steam Sterilization

[00190837008338]

Moist Heat or Steam Sterilization

[00190837008338]

Moist Heat or Steam Sterilization

[00190837008338]

Moist Heat or Steam Sterilization

[00190837008338]

Moist Heat or Steam Sterilization

[00190837008338]

Moist Heat or Steam Sterilization

[00190837008338]

Moist Heat or Steam Sterilization

[00190837008338]

Moist Heat or Steam Sterilization

[00190837008338]

Moist Heat or Steam Sterilization

[00190837008338]

Moist Heat or Steam Sterilization

[00190837008338]

Moist Heat or Steam Sterilization

[00190837008338]

Moist Heat or Steam Sterilization

[00190837008338]

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: 2016-06-14

On-Brand Devices [NEO SL Anterior Cervical Plate System]

• 00190837008383: SL5-110
• 00190837008376: SL5-105
• 00190837008369: SL5-100
• 00190837008352: SL5-095
• 00190837008345: SL4-090
• 00190837008338: SL4-086
• 00190837008321: SL4-082
• 00190837008314: SL4-078
• 00190837008307: SL4-074
• 00190837008291: SL3-074
• 00190837008284: SL3-070
• 00190837008277: SL3-067
• 00190837008260: SL3-064
• 00190837008253: SL3-061
• 00190837008246: SL3-058
• 00190837008239: SL3-055
• 00190837008222: SL3-052
• 00190837008215: SL2-050
• 00190837008208: SL2-048
• 00190837008192: SL2-046
• 00190837008185: SL2-044
• 00190837008178: SL2-042
• 00190837008161: SL2-040
• 00190837008154: SL2-038
• 00190837008147: SL2-036
• 00190837008130: SL2-034
• 00190837008123: SL1-034
• 00190837008116: SL1-032
• 00190837008109: SL1-030
• 00190837008093: SL1-028
• 00190837008086: SL1-026
• 00190837008079: SL1-024
• 00190837008062: SL1-022
• 00190837008055: SL1-020