SpineWorks Anterior Lumbar Device A1226-6

GUDID M711A122660

Polymeric spinal interbody fusion cage

Primary Device ID	M711A122660
NIH Device Record Key	6f5e8f4d-3104-430b-88e5-c3a9bd7fdd78
Commercial Distribution Status	In Commercial Distribution
Brand Name	SpineWorks Anterior Lumbar Device
Version Model Number	A1226-6
Catalog Number	A1226-6
Company DUNS	156567492
Company Name	Innovasis, 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

Phone	801-261-2236
Email	info@innovasis.com

Height

12 Millimeter

Device Issuing Agency	Device ID
HIBCC	M711A122660 [Primary]

MAX	Intervertebral Fusion Device With Bone Graft, Lumbar

Steralize Prior To Use	true
Device Is Sterile	false

[M711A122660]

Moist Heat or Steam Sterilization