FDA.reportPublic FDA data

Kora Spinal System

Primary DI
08809214540089
Brand
Kora Spinal System
Company
Medyssey Co., Ltd.
Model
MRHP65115
Device description
Reduction Hole Poly axial type (10mm Reduction) (Ø2.5 Cannula) Ø6.5x115mm
Published
2025-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809214540089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809214540089088092145400898809214540089

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
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
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
08800311596603Medyssey Poseidon OCT Spinal Fixation SystemR351852026-01-30
08800311596610Medyssey Poseidon OCT Spinal Fixation SystemR351952026-01-30
08800311595132NASPNDB-2002026-01-27
08800311595149NASPNDB-2502026-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115935615Counter Torque STPREMIA SPINE LTDMNI2026-05-25
00763000887131CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00763000887162CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00763000887179CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00841732117860PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2023-09-07
00841732117877PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2023-09-07
00841732117884PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2023-09-07
00841732117891PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2023-09-07
00841732117907PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2023-09-07
00841732117914PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2023-09-07
00841732118959PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
00841732118966PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
00841732118973PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
00841732118980PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
00841732119017PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
00841732119024PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
00841732119031PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
00841732119048PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
00841732119055PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
00841732119062PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
00841732119079PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
088000333846944CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847174CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847244CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847484CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847554CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847624CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847794CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847864CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333850974CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-12-11