FDA.reportPublic FDA data

Unity

Primary DI
08800113999565
Brand
Unity
Company
DIOMEDICAL CO.,LTD.
Model
A
Catalog number
000E013550
Device description
Unity Erodium SIJ Headless Compression Screw - OD13.5xL50
Published
2022-07-07
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
OURSacroiliac joint fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173201000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173201000UNITY Sacroiliac Joint Fixation SystemHuvexel Co. , Ltd.2018-04-26OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800113999565PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800113999565088001139995658800113999565

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
M719GSIX1270Sacroiliac Joint Fusion SystemGenesys Orthopedics Systems LLCOUR2026-10-19
B387T5II51300SiJoin T5 TitaniumVGI MEDICAL, LLCOUR2026-10-09
B387T5II51310SiJoin T5 TitaniumVGI MEDICAL, LLCOUR2026-10-09
00810131884055TiLink-L Rescue Drill GuideSurgentec, LLCOUR2026-09-25
00810131884062TiLink-L Rescue DilatorSurgentec, LLCOUR2026-09-25
00810131884079TiLink-L Rescue Impact CapSurgentec, LLCOUR2026-09-25
00810131884086TiLink-L Rescue screw Drill bit – 10.5mmSurgentec, LLCOUR2026-09-25
00810131884857TiLink-L Sterilization Tray – Double StackSurgentec, LLCOUR2026-09-25
00810131884864TiLink-L Rescue CaddySurgentec, LLCOUR2026-09-25
M719GSIX1210TiLockGenesys Orthopedics Systems LLCOUR2026-08-18
M719G120050SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120060SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120070SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120080SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120090SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120100SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120110SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120120SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120130SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120000SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719G120010SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719G120020SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719G120030SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719G120040SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719GSIX1260SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719GL201TL0SIros-XGenesys Orthopedics Systems LLCOUR2026-07-23
00889929072745NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCOUR2026-07-17
18257200140084Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200140091Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143368Firebird SI FusionOrthofix US LLCOUR2026-07-17