Kinetic Dynamic Anterior Cervical Plate System

GUDID 00190837004835

Life Spine, Inc.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00190837004835
• NIH Device Record Key: bfabb7c7-d096-43aa-b45b-caa346781e03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kinetic Dynamic Anterior Cervical Plate System
• Version Model Number: 1860-034
• 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	00190837004835 [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

[00190837004835]

Moist Heat or Steam Sterilization

[00190837004835]

Moist Heat or Steam Sterilization

[00190837004835]

Moist Heat or Steam Sterilization

[00190837004835]

Moist Heat or Steam Sterilization

[00190837004835]

Moist Heat or Steam Sterilization

[00190837004835]

Moist Heat or Steam Sterilization

[00190837004835]

Moist Heat or Steam Sterilization

[00190837004835]

Moist Heat or Steam Sterilization

[00190837004835]

Moist Heat or Steam Sterilization

[00190837004835]

Moist Heat or Steam Sterilization

[00190837004835]

Moist Heat or Steam Sterilization

[00190837004835]

Moist Heat or Steam Sterilization

[00190837004835]

Moist Heat or Steam Sterilization

[00190837004835]

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: 2016-06-08

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

• 00190837005047: 1812-111
• 00190837005030: 1812-101
• 00190837005023: 1810-091
• 00190837005016: 1810-083
• 00190837005009: 1810-073
• 00190837004996: 1810-067
• 00190837004989: 1880-070
• 00190837004972: 1880-067
• 00190837004965: 1880-061
• 00190837004958: 1880-059
• 00190837004941: 1880-055
• 00190837004934: 1880-053
• 00190837004927: 1860-052
• 00190837004910: 1860-050
• 00190837004903: 1860-048
• 00190837004897: 1860-046
• 00190837004880: 1860-044
• 00190837004873: 1860-042
• 00190837004866: 1860-040
• 00190837004859: 1860-038
• 00190837004842: 1860-036
• 00190837004835: 1860-034
• 00190837004828: 1840-036
• 00190837004811: 1840-034
• 00190837004804: 1840-032
• 00190837004798: 1840-030
• 00190837004781: 1840-028
• 00190837004774: 1840-026
• 00190837004767: 1840-024
• 00190837004750: 1840-022
• 00190837004743: 1840-021