FDA.reportPublic FDA data

Fortis ACP

Primary DI
08800039802024
Brand
Fortis ACP
Company
DIOMEDICAL CO.,LTD.
Model
A
Catalog number
TP.IN.0003
Device description
Plate Bender
Published
2019-02-08
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
KWQAppliance, fixation, spinal intervertebral body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173099000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173099000Fortis and Hana Anterior Cervical Plate SystemHuvexel Co. , Ltd.2017-11-30KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800039802024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800039802024088000398020248800039802024

GMDN Terms#

Term, Definition table
TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. It is typically in the form of pliers, a rod-like (e.g., pin) or bench-top device. This is a reusable device.

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
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
08800039830195Fortis ACPATPA.PL.01242019-07-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613153045755XIA IStryker CorporationKWQ2014-12-08
07613153045762XIA IIStryker CorporationKWQ2014-12-08
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07613153045854XIA IIStryker CorporationKWQ2014-12-08
07613153045878XIA IIStryker CorporationKWQ2014-12-08
07613153045885XIA IIStryker CorporationKWQ2014-12-08
07613153045892XIA IIStryker CorporationKWQ2014-12-08
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07613153045915XIA IIStryker CorporationKWQ2014-12-08
07613153045922XIA IIStryker CorporationKWQ2014-12-08
07613153045939XIA IIStryker CorporationKWQ2014-12-08
07613153045960XIA IIStryker CorporationKWQ2014-12-08
07613153046011XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046028XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
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07613153046042XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046059XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046066XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046073XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046103XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
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07613153046127XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
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