Neo 113-947

GUDID 00190837035334

OCT Plate Bender

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	00190837035334
NIH Device Record Key	572e777b-88f6-42fc-b14c-12e9f28f053c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Neo
Version Model Number	113-947
Catalog Number	113-947
Company DUNS	183641617
Company Name	Life Spine, Inc.
Device Count	1
DM Exempt	false
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	false
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	00190837035334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K040844

FDA Product Code

KWQ	Appliance, fixation, spinal intervertebral body