FDA.reportPublic FDA data

Kora Spinal System

Primary DI
08806364657711
Brand
Kora Spinal System
Company
Medyssey Co., Ltd.
Model
DMHP8065
Device description
Hole Poly axial type (Dual Thread) (Ø2.5 Cannula) Ø8.0x65mm
Published
2025-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806364657711PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806364657711088063646577118806364657711

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688211503
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
08806364689439Kora Spinal SystemMHP65202026-10-01
08806364690077Kora Spinal SystemMHP85252026-10-01
08809974423714Hedjet SystemDZRHHPS601002026-10-01
08809974435823Hedjet System13DZRPS60452026-10-01
08800311596863NAPNPS-0032026-03-12
08800311596696NANNSS-0022026-03-09
08800311596665NANXVC-0022026-02-19
08800311596474Medyssey Poseidon OCT Spinal Fixation SystemR350552026-01-30
08800311596481Medyssey Poseidon OCT Spinal Fixation SystemR350652026-01-30
08800311596498Medyssey Poseidon OCT Spinal Fixation SystemR350752026-01-30
08800311596504Medyssey Poseidon OCT Spinal Fixation SystemR350852026-01-30
08800311596511Medyssey Poseidon OCT Spinal Fixation SystemR350952026-01-30
08800311596528Medyssey Poseidon OCT Spinal Fixation SystemR351052026-01-30
08800311596535Medyssey Poseidon OCT Spinal Fixation SystemR351152026-01-30
08800311596542Medyssey Poseidon OCT Spinal Fixation SystemR351252026-01-30
08800311596559Medyssey Poseidon OCT Spinal Fixation SystemR351352026-01-30
08800311596566Medyssey Poseidon OCT Spinal Fixation SystemR351452026-01-30
08800311596573Medyssey Poseidon OCT Spinal Fixation SystemR351552026-01-30
08800311596580Medyssey Poseidon OCT Spinal Fixation SystemR351652026-01-31
08800311596597Medyssey Poseidon OCT Spinal Fixation SystemR351752026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806364689439Kora Spinal SystemMedyssey Co., Ltd.MNI2026-10-01
08806364689439Kora Spinal SystemMedyssey Co., Ltd.MNH2026-10-01
08806364690077Kora Spinal SystemMedyssey Co., Ltd.MNH2026-10-01
08806364690077Kora Spinal SystemMedyssey Co., Ltd.MNI2026-10-01
10888857001428DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001428DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001497DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24
10888857001497DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001527DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001527DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24
10888857001589DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001589DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24
10888857001619DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24
10888857001619DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001640DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001640DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24