NEO / Kinetic Anterior Cervical Plate System

GUDID 00190837004613

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837004613
• NIH Device Record Key: dde361f6-dae8-44c5-980b-92b1e3c364f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEO / Kinetic Anterior Cervical Plate System
• Version Model Number: 101-016
• 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	00190837004613 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062643

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00190837004613]

Moist Heat or Steam Sterilization

[00190837004613]

Moist Heat or Steam Sterilization

[00190837004613]

Moist Heat or Steam Sterilization

[00190837004613]

Moist Heat or Steam Sterilization

[00190837004613]

Moist Heat or Steam Sterilization

[00190837004613]

Moist Heat or Steam Sterilization

[00190837004613]

Moist Heat or Steam Sterilization

[00190837004613]

Moist Heat or Steam Sterilization

[00190837004613]

Moist Heat or Steam Sterilization

[00190837004613]

Moist Heat or Steam Sterilization

[00190837004613]

Moist Heat or Steam Sterilization

[00190837004613]

Moist Heat or Steam Sterilization

[00190837004613]

Moist Heat or Steam Sterilization

[00190837004613]

Moist Heat or Steam Sterilization

[00190837004613]

Moist Heat or Steam Sterilization

[00190837004613]

Moist Heat or Steam Sterilization

[00190837004613]

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: 2016-06-13

On-Brand Devices [NEO / Kinetic Anterior Cervical Plate System]

• 00190837005191: 203-018
• 00190837005184: 203-016
• 00190837005177: 203-014
• 00190837005160: 203-012
• 00190837005153: 203-010
• 00190837005146: 202-018
• 00190837005139: 202-016
• 00190837005122: 202-014
• 00190837005115: 202-012
• 00190837005108: 202-010
• 00190837005092: 201-018
• 00190837005085: 201-016
• 00190837005078: 201-014
• 00190837005061: 201-012
• 00190837005054: 201-010
• 00190837004736: 111-001
• 00190837004729: 103-018
• 00190837004712: 103-016
• 00190837004705: 103-014
• 00190837004699: 103-012
• 00190837004682: 103-010
• 00190837004675: 102-018
• 00190837004668: 102-016
• 00190837004651: 102-014
• 00190837004644: 102-012
• 00190837004637: 102-010
• 00190837004620: 101-018
• 00190837004613: 101-016
• 00190837004606: 101-014
• 00190837004590: 101-012
• 00190837004583: 101-010
• 00190837036775: Neo Fixed Angle Drill Guide
• 00190837036805: Kinetic Single-Barrel Clip-On Fixed Angle Drill Guide
• 00190837036799: Kinetic Fixed Angle Drill Guide
• 00190837036782: Kinetic Distractor Clip
• 00190837036768: 14mm Fixation Pin
• 00190837036751: MIS CT Handle
• 00190837036744: Custom Screw Caddy, NEO / Kinetic
• 00190837036737: Custom Locking Bone Screw Driver
• 00190837036720: Single Barrel Fixed Angle Drill Guide (Left)
• 00190837036713: Single Barrel Fixed Angle Drill Guide (Right)
• 00190837036706: Locking Fixation Pin Driver
• 00190837036690: Sleeved Screw Driver
• 00190837036683: Fluted Fixation Pin
• 00190837036676: Drill Guide
• 00190837036669: Kinetic-Iris 2-Level, 44mm
• 00190837036652: KINETIC SL Dynamic Distractor Clip, 1.6mm (PEEK)
• 00190837036645: 2mm KINETIC SL Distractor
• 00190837036638: 1mm KINETIC Distractor
• 00190837036621: NEO / KINETIC FT Screw Caddy