FDA.reportPublic FDA data

4CIS PEEK PLIF CAGE SYSTEM

Primary DI
08806373546051
Brand
4CIS PEEK PLIF CAGE SYSTEM
Company
ALPHA AI CO.,LTD.
Model
5901-0026
Catalog number
5901-0026
Device description
PEEK PLIF Cage Holder
Published
2017-05-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K092162000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K0921620004CIS PEEK, PLIF AND TLIF CAGE SYSTEMSolco Biomedical Co., Ltd.2010-01-06MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806373546051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806373546051088063735460518806373546051

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10888857223783CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223790CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223868CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223875CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223882CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223899CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223967CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223974CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223981CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223998CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857217355CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
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10888857217492CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217577CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217584CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217591CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217669CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19