AccessGUDID - DEVICE: ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD16xH05 (ISRO1618A05CA1)

GUDID

Device Identifier (DI) Information

Brand Name: ROMERO SELF-ANCHORED CERVICAL CAGE, W18xD16xH05
Version or Model: ISRO1618A05CA1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ISRO1618A05CA1
Company Name: Spineup, Inc.

Primary DI Number: ISRO1618A05CA1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116999578 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60762	Polymeric spinal interbody fusion cage	A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical
ODP	Intervertebral Fusion Device With Bone Graft, Cervical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Depth: 16 Millimeter
Angle: 6 degree
Height: 05 Millimeter
Width: 18 Millimeter

Device Record Status

Public Device Record Key: 8c10f18a-cfe7-4f53-be09-d2734624a84d
Public Version Date: November 17, 2023
Public Version Number: 2
DI Record Publish Date: October 03, 2023