FDA.reportPublic FDA data

Rexious

Primary DI
08800039828574
Brand
Rexious
Company
DIOMEDICAL CO.,LTD.
Model
A
Catalog number
AC.RA.0070
Device description
CoCr Straight Rod D5.5 x 70mm
Published
2020-07-14
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
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173131000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173131000Rexious Spinal Fixation SystemHuvexel Co. , Ltd.2017-12-08NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800039828574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800039828574088000398285748800039828574

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
00197157059521ZAVATION RODZavation LLCNKB2026-06-04
00197157059538ZAVATION RODZavation LLCNKB2026-06-04
00197157059545ZAVATION RODZavation LLCNKB2026-06-04
00197157059552ZAVATION RODZavation LLCNKB2026-06-04
00197157059569ZAVATION RODZavation LLCNKB2026-06-04
00197157059576ZAVATION RODZavation LLCNKB2026-06-04
00197157059583ZAVATION RODZavation LLCNKB2026-06-04
00197157059590ZAVATION RODZavation LLCNKB2026-06-04
00197157059606ZAVATION RODZavation LLCNKB2026-06-04
00197157059613ZAVATION RODZavation LLCNKB2026-06-04
00197157059620ZAVATION RODZavation LLCNKB2026-06-04
00197157059637ZAVATION RODZavation LLCNKB2026-06-04
00197157059644ZAVATION RODZavation LLCNKB2026-06-04
00197157059651ZAVATION RODZavation LLCNKB2026-06-04
00197157059668ZAVATION RODZavation LLCNKB2026-06-04
00197157059491ZAVATION RODZavation LLCNKB2026-06-03
00197157059507ZAVATION RODZavation LLCNKB2026-06-03
00197157059514ZAVATION RODZavation LLCNKB2026-06-03
00840311244874Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311244881Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311244904Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311244928Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311244935Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311244942Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311245017Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311245024Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311245062Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311245079Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311245130Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311245154Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03