NEO Anterior Cervical Plate System

GUDID 00190837007973

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	00190837007973
NIH Device Record Key	eaaff2f6-61b0-42f7-8fab-d55d3c743e85
Commercial Distribution Status	In Commercial Distribution
Brand Name	NEO Anterior Cervical Plate System
Version Model Number	110-078
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	00190837007973 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K040844

FDA Product Code

KWQ	Appliance, Fixation, Spinal Intervertebral Body