FDA.reportPublic FDA data

4CIS BLACK MARLIN PLIF CAGE SYSTEM

Primary DI
00840185318596
Brand
4CIS BLACK MARLIN PLIF CAGE SYSTEM
Company
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
Model
AISP-2016-2211
Catalog number
2016-2211
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.
Published
2026-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213653000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2136530004CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEMSolco Biomedical Company India Private Limited2022-12-19MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840185318596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840185318596008401853185968401853185960840185318596

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle0degree
Length22Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
868354728
Device count
1
Combination product
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008401853005534CIS SARA SPINE SYSTEMAISP-1012-65401012-65402021-03-26
008401853005604CIS SARA SPINE SYSTEMAISP-1012-65451012-65452021-03-26
008401853005774CIS SARA SPINE SYSTEMAISP-1012-65501012-65502021-03-26
008401853005844CIS SARA SPINE SYSTEMAISP-1012-65551012-65552021-03-26
008401853273524CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-02140105-02142026-05-29
008401853273694CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01340105-01342026-05-29
008401853273764CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01050105-01052026-05-29
008401853273834CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01060105-01062026-05-29
008401853273904CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01070105-01072026-05-29
008401853274064CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01080105-01082026-05-29
008401853274134CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01090105-01092026-05-29
008401853274204CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01100105-01102026-05-29
008401853274374CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01110105-01112026-05-29
008401853274444CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01120105-01122026-05-29
008401853274514CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01230105-01232026-05-29
008401853274684CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01240105-01242026-05-29
008401853274754CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01250105-01252026-05-29
008401853274824CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01260105-01262026-05-29
008401853274994CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01270105-01272026-05-29
008401853275054CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01280105-01282026-05-29

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Primary DI, Brand, Company table
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00843511102340Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
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00843511102371Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
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00843511102395Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
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00843511102425Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22