ROMERO CERVICAL CAGE, W16xD12xH09 ISRO1216A09CB1

GUDID B806ISRO1216A09CB10

Polymeric spinal interbody fusion cage

Primary Device ID	B806ISRO1216A09CB10
NIH Device Record Key	bb24ed49-2bc8-42c4-a0e1-0a96dd243a2b
Commercial Distribution Status	In Commercial Distribution
Brand Name	ROMERO CERVICAL CAGE, W16xD12xH09
Version Model Number	ISRO1216A09CB1
Catalog Number	ISRO1216A09CB1
Company DUNS	116999578
Company Name	Spineup, 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	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	B806ISRO1216A09CB10 [Primary]

OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical

Steralize Prior To Use	false
Device Is Sterile	true

ISRO1216L09CB1	The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody
ISRO1216A09CB1	The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody
B806ISRO1216L09CB10	The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody
B806ISRO1216A09CB10	The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody