Device
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.
Manufacturer
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
Model: AISP-2018-2512
Catalog: 2018-2512
DI: 00840185319739
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
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.
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
f366e9ba-7e34-4644-b26f-901a960857ea
Distribution Status:
In Commercial Distribution
DUNS Number:
868354728
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
Yes
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00840185319739
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 38161
Name: Metallic spinal interbody fusion cage
Definition:
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.
FDA Product Codes
MAX
Intervertebral Fusion Device With Bone Graft, Lumbar
Premarket Submissions
Submission Number:
K213653
Supplement Number:
000
Device Sizes
Item #1 - Size - @attributes - Unit:
degree
Item #1 - Size - @attributes - Value:
8
Item #1 - Size Type:
Angle
Item #2 - Size - @attributes - Unit:
Millimeter
Item #2 - Size - @attributes - Value:
25
Item #2 - Size Type:
Length