Rexious

Primary DI
08800113938656
Brand
Rexious
Company
DIOMEDICAL CO.,LTD.
Model
A
Catalog number
BT.MS.100035
Device description
Mono-Axial Pedicle E Type (Single & Self Tapping) (L1)53x(L2)35x(A)10x(B)13.5mm-Ø6.0
Published
2021-05-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNHOrthosis, spondylolisthesis spinal fixation
MNIOrthosis, spinal pedicle fixation
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122229000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122229000VICEROY SPINAL SYSTEMTorrey Spine2012-11-20NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800113938656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800113938656088001139386568800113938656

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+82313699470info@huvexel.com

Regulatory Flags#

DUNS number
557795909
Device count
1
DM exempt
true
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
08800039800754Hana ACPAUP.IN.00052019-02-08
08800039802024Fortis ACPATP.IN.00032019-02-08
08800039829991Fortis ACPATPA.PL.01102019-07-19
08800039830003Fortis ACPATPA.PL.01122019-07-19
08800039830010Fortis ACPATPA.PL.01142019-07-19
08800039830027Fortis ACPATPA.PL.01162019-07-19
08800039830034Fortis ACPATPA.PL.01182019-07-19
08800039830041Fortis ACPATPA.PL.01202019-07-19
08800039830058Fortis ACPATPA.PL.02262019-07-19
08800039830065Fortis ACPATPA.PL.02282019-07-19
08800039830072Fortis ACPATPA.PL.02302019-07-19
08800039830089Fortis ACPATPA.PL.02322019-07-19
08800039830096Fortis ACPATPA.PL.02342019-07-19
08800039830102Fortis ACPATPA.PL.03432019-07-19
08800039830119Fortis ACPATPA.PL.03462019-07-19
08800039830126Fortis ACPATPA.PL.03492019-07-19
08800039830133Fortis ACPATPA.PL.03522019-07-19
08800039830140Fortis ACPATPA.PL.03552019-07-19
08800039830157Fortis ACPATPA.PL.03582019-07-19
08800039830188Fortis ACPATPA.PL.01222019-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115932508Tower Guide STPREMIA SPINE LTDMNI2026-07-23
07290115932508Tower Guide STPREMIA SPINE LTDMNH2026-07-23
07290115932508Tower Guide STPREMIA SPINE LTDNKB2026-07-23
M719GL201TL0SIros-XGenesys Orthopedics Systems LLCNKB2026-07-23
00840019935319Reform TiPRECISION SPINE, INC.NKB2019-10-07
00840019935364Reform TiPRECISION SPINE, INC.NKB2019-10-07
00840019934800Reform TiPRECISION SPINE, INC.NKB2019-10-04
00840019934817Reform TiPRECISION SPINE, INC.NKB2019-10-04
00840019934824Reform TiPRECISION SPINE, INC.NKB2019-10-04
00840019934831Reform TiPRECISION SPINE, INC.NKB2019-10-04
00840019934725Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934732Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934749Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934756Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934763Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934770Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934787Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934794Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934251Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934268Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934275Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934282Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934299Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934305Reform TIPRECISION SPINE, INC.NKB2019-09-10
00840019934312Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934329Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934336Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934343Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934350Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934367Reform TIPRECISION SPINE, INC.NKB2019-09-10