Kinetic-SL Dynamic Anterior Cervical Plate System

GUDID 00190837005344

Life Spine, Inc.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00190837005344
• NIH Device Record Key: 64bbfb49-3805-40d0-980a-309b97962eba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kinetic-SL Dynamic Anterior Cervical Plate System
• Version Model Number: 1282-044
• 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	00190837005344 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073479

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00190837005344]

Moist Heat or Steam Sterilization

[00190837005344]

Moist Heat or Steam Sterilization

[00190837005344]

Moist Heat or Steam Sterilization

[00190837005344]

Moist Heat or Steam Sterilization

[00190837005344]

Moist Heat or Steam Sterilization

[00190837005344]

Moist Heat or Steam Sterilization

[00190837005344]

Moist Heat or Steam Sterilization

[00190837005344]

Moist Heat or Steam Sterilization

[00190837005344]

Moist Heat or Steam Sterilization

[00190837005344]

Moist Heat or Steam Sterilization

[00190837005344]

Moist Heat or Steam Sterilization

[00190837005344]

Moist Heat or Steam Sterilization

[00190837005344]

Moist Heat or Steam Sterilization

[00190837005344]

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: 2016-06-10

On-Brand Devices [Kinetic-SL Dynamic Anterior Cervical Plate System]

• 00190837005658: 1285-111
• 00190837005641: 1285-101
• 00190837005634: 1284-091
• 00190837005627: 1284-083
• 00190837005610: 1284-073
• 00190837005603: 1284-067
• 00190837005443: 1283-067
• 00190837005436: 1283-065
• 00190837005429: 1283-061
• 00190837005412: 1283-059
• 00190837005405: 1283-055
• 00190837005399: 1283-053
• 00190837005382: 1282-052
• 00190837005375: 1282-050
• 00190837005368: 1282-048
• 00190837005351: 1282-046
• 00190837005344: 1282-044
• 00190837005337: 1282-042
• 00190837005320: 1282-040
• 00190837005313: 1282-038
• 00190837005306: 1282-036
• 00190837005290: 1282-034
• 00190837005283: 1281-036
• 00190837005276: 1281-034
• 00190837005269: 1281-032
• 00190837005252: 1281-030
• 00190837005245: 1281-028
• 00190837005238: 1281-026
• 00190837005221: 1281-024
• 00190837005214: 1281-022
• 00190837005207: 1281-021
• 00190837037383: Kinetic SL Single Barrel Snap-On Drill/Tap Guide, Distal
• 00190837037376: Kinetic SL Single Barrel Snap-On Drill/Tap Guide, Intermedia
• 00190837037291: Custom Cervical Screw Driver
• 00190837037468: SL FT Variable Screw - 24mm length, D=4mm
• 00190837037451: SL FT Variable Screw - 22mm length, D=4mm
• 00190837037444: SL FT Variable Screw - 20mm length, D=4mm
• 00190837037437: Kinetic-SL Fixation Pin
• 00190837037420: SL Dynamic Distractor 1mm
• 00190837037413: Pro-Link Screwdriver, Straight Tapered Hex, AO Power
• 00190837037406: NEO-UL Hexalobe T10 Screwdriver, AO Power
• 00190837037390: ACPS Hexalobe T10 Screwdriver, AO Power
• 00190837037369: Cervical Screw Driver, AO Drive
• 00190837037352: Solstice Adjustable Drill Guide
• 00190837037345: Cervical Screw Driver, Spin Cap Handle
• 00190837037338: Drill Guide
• 00190837037321: Custom 3.5mm Rod Inserter, Rachet Style
• 00190837037314: Locking Cap Final Torque Driver Shaft, Short
• 00190837037307: Temporary Fixation Pin
• 00190837037284: Micro Variable Angle Drill Guide