SpineWorks Anterior Lumbar Device A1630-6

GUDID M711A163060

Polymeric spinal interbody fusion cage

Primary Device ID	M711A163060
NIH Device Record Key	81d0b88d-837c-4bd9-8b07-5613804f44a3
Commercial Distribution Status	In Commercial Distribution
Brand Name	SpineWorks Anterior Lumbar Device
Version Model Number	A1630-6
Catalog Number	A1630-6
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

16 Millimeter

Device Issuing Agency	Device ID
HIBCC	M711A163060 [Primary]

MAX	Intervertebral Fusion Device With Bone Graft, Lumbar

Steralize Prior To Use	true
Device Is Sterile	false

[M711A163060]

Moist Heat or Steam Sterilization