ROMERO CERVICAL CAGE, W14xD12xH04 ISRO1214L04CB1

GUDID B806ISRO1214L04CB10

The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody cage with radiographic markers and Titanium (Ti -6Al-4V ELI) fixation screws for cages with screw holes.

Spineup, Inc.

Polymeric spinal interbody fusion cage
Primary Device IDB806ISRO1214L04CB10
NIH Device Record Key5835beb5-f336-45ce-a570-df02e3fe8a24
Commercial Distribution StatusIn Commercial Distribution
Brand NameROMERO CERVICAL CAGE, W14xD12xH04
Version Model NumberISRO1214L04CB1
Catalog NumberISRO1214L04CB1
Company DUNS116999578
Company NameSpineup, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone786-910-0234
Emailcontact@upgroup.tech
Phone786-910-0234
Emailcontact@upgroup.tech
Phone786-910-0234
Emailcontact@upgroup.tech
Phone786-910-0234
Emailcontact@upgroup.tech
Phone786-910-0234
Emailcontact@upgroup.tech
Phone786-910-0234
Emailcontact@upgroup.tech
Phone786-910-0234
Emailcontact@upgroup.tech
Phone786-910-0234
Emailcontact@upgroup.tech
Phone786-910-0234
Emailcontact@upgroup.tech
Phone786-910-0234
Emailcontact@upgroup.tech

Device Dimensions

Width14 Millimeter
Depth12 Millimeter
Angle6 degree
Height4 Millimeter
Width14 Millimeter
Depth12 Millimeter
Angle6 degree
Height4 Millimeter
Width14 Millimeter
Depth12 Millimeter
Angle6 degree
Height4 Millimeter
Width14 Millimeter
Depth12 Millimeter
Angle6 degree
Height4 Millimeter
Width14 Millimeter
Depth12 Millimeter
Angle6 degree
Height4 Millimeter
Width14 Millimeter
Depth12 Millimeter
Angle6 degree
Height4 Millimeter
Width14 Millimeter
Depth12 Millimeter
Angle6 degree
Height4 Millimeter
Width14 Millimeter
Depth12 Millimeter
Angle6 degree
Height4 Millimeter
Width14 Millimeter
Depth12 Millimeter
Angle6 degree
Height4 Millimeter
Width14 Millimeter
Depth12 Millimeter
Angle6 degree
Height4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB806ISRO1214L04CB10 [Primary]

FDA Product Code

OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2025-12-11
Device Publish Date2023-08-24

On-Brand Devices [ROMERO CERVICAL CAGE, W14xD12xH04]

ISRO1214L04CB1The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody
ISRO1214A04CB1The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody
B806ISRO1214L04CB10The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody
B806ISRO1214A04CB10The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.