AccessGUDID - DEVICE: 4CIS BLACK MARLIN PLIF CAGE SYSTEM (00840185317841)

GUDID

Device Identifier (DI) Information

Brand Name: 4CIS BLACK MARLIN PLIF CAGE SYSTEM
Version or Model: AISP-1655-3215
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1655-3215
Company Name: SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED

Primary DI Number: 00840185317841
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 868354728 *Terms of Use

Device Description: Interbody fusion cage system for thoracolumbar spine used in PLIF procedure, made of titanium alloy and/or PEEK, designed to maintain disc height and promote spinal fusion.

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
38161	Metallic 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 typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] 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 packaged with the cage.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K213653	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Angle: 8 degree
Length: 32 Millimeter

Device Record Status

Public Device Record Key: 5a893770-408d-4aac-9923-d711bc7281bb
Public Version Date: May 04, 2026
Public Version Number: 1
DI Record Publish Date: April 24, 2026