FDA.reportPublic FDA data

4CIS® Spinal System and 4CIS® Low Back System

Primary DI
08806373524165
Brand
4CIS® Spinal System and 4CIS® Low Back System
Company
ALPHA AI CO.,LTD.
Model
4212-0001
Catalog number
4212-0001
Device description
Nut
Published
2026-04-15
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
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043578000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043578000THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEMSolco Biomedical Co., Ltd.2005-03-07MNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806373524165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806373524165088063735241658806373524165

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone set screwA small, implantable, non-bioabsorbable disc, threaded on its outside surface, intended to be threaded into the internal proximal end of a spinal bone screw head/rod adaptor, anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
687844241
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800377762103Spinal Fusion Cage SystemDPUC-40J8DPUC-40J82024-02-22
08800377762127Spinal Fusion Cage SystemDPUC-40JADPUC-40JA2024-02-22
08800377762141Spinal Fusion Cage SystemDPUC-40JCDPUC-40JC2024-02-22
08800377762165Spinal Fusion Cage SystemDPUC-40JEDPUC-40JE2024-02-22
08800377762363Spinal Fusion Cage SystemDPUC-45J8DPUC-45J82024-02-22
08800377762387Spinal Fusion Cage SystemDPUC-45JADPUC-45JA2024-02-22
08800377762400Spinal Fusion Cage SystemDPUC-45JCDPUC-45JC2024-02-22
08800377762424Spinal Fusion Cage SystemDPUC-45JEDPUC-45JE2024-02-22
08800377762622Spinal Fusion Cage SystemDPUC-50J8DPUC-50J82024-02-22
08800377762646Spinal Fusion Cage SystemDPUC-50JADPUC-50JA2024-02-22
08800377762660Spinal Fusion Cage SystemDPUC-50JCDPUC-50JC2024-02-22
08800377762684Spinal Fusion Cage SystemDPUC-50JEDPUC-50JE2024-02-22
08800377762882Spinal Fusion Cage SystemDPUC-55J8DPUC-55J82024-02-22
08800377762905Spinal Fusion Cage SystemDPUC-55JADPUC-55JA2024-02-22
08800377762929Spinal Fusion Cage SystemDPUC-55JCDPUC-55JC2024-02-22
08800377762943Spinal Fusion Cage SystemDPUC-55JEDPUC-55JE2024-02-22
08800313887983SOLCO 4CIS® General Plate System96-5081096-508102026-04-21
088003138870444CIS® Spinal System and 4CIS® Low Back System62-4504562-450452026-04-15
088003138870514CIS® Spinal System and 4CIS® Low Back System62-5505062-550502026-04-15
088003138870684CIS® Spinal System and 4CIS® Low Back System62-6503062-650302026-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00613994887955TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-09-17
00613994887955TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-09-17
00885074494722TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-08-05
00885074494722TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-08-05
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04546540147936XIA IStryker CorporationMNH2014-12-08
04546540147936XIA IStryker CorporationMNI2014-12-08
04546540147974XIA IStryker CorporationMNH2014-12-08
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04546540147981XIA IStryker CorporationMNI2014-12-08
04546540147981XIA IStryker CorporationMNH2014-12-08
04546540147998XIA IStryker CorporationMNI2014-12-08
04546540147998XIA IStryker CorporationMNH2014-12-08