FDA.reportPublic FDA data

Spinal Fusion Cage System

Primary DI
08800377762387
Brand
Spinal Fusion Cage System
Company
ALPHA AI CO.,LTD.
Model
DPUC-45JA
Catalog number
DPUC-45JA
Device description
4CIS® Dunes PEEK DLIF Cage 12, 45x18x10mm
Published
2024-02-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K190563000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1905630004CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF CageSolco Biomedical Co., Ltd.2019-09-18MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800377762387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800377762387088003777623878800377762387

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric 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 in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] 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 included with the device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
687844241
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
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
088003138870754CIS® Spinal System and 4CIS® Low Back System62-6505562-650552026-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606185110LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185127LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185134LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185141LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185158LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185165LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196024VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196031VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196048VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.MAX2026-09-22
10888857461819CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
04546540665720AVS NAVIGATORStryker CorporationMAX2016-09-24
10888857218772CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219489CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219595CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
07613153046196AVS PLStryker CorporationMAX2015-09-14
07613153046202AVS PLStryker CorporationMAX2015-09-14
07613153046219AVS PLStryker CorporationMAX2015-09-14
07613153046226AVS PLStryker CorporationMAX2015-09-14
07613153046233AVS PLStryker CorporationMAX2015-09-14
07613153046288AVS PLStryker CorporationMAX2015-09-14
07613153046295AVS PLStryker CorporationMAX2015-09-14
07613153046301AVS PLStryker CorporationMAX2015-09-14
07613153046318AVS PLStryker CorporationMAX2015-09-14
07613153046325AVS PLStryker CorporationMAX2015-09-14
07613153046332AVS PLStryker CorporationMAX2015-09-14
07613153046349AVS PLStryker CorporationMAX2015-09-14