Dyna-Link

GUDID 00190837078607

Life Spine, Inc.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

Primary Device ID	00190837078607
NIH Device Record Key	edde38d3-f312-46f7-9c0c-c7870957f12f
Commercial Distribution Status	In Commercial Distribution
Brand Name	Dyna-Link
Version Model Number	85-655-25
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	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	00190837078607 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K191834

FDA Product Code

OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar