FDA.reportPublic FDA data

Fortis ACP

Primary DI
08800039802062
Brand
Fortis ACP
Company
DIOMEDICAL CO.,LTD.
Model
A
Catalog number
TP.IN.0007
Device description
Drill bit - 12 mm
Published
2019-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
08800039802062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800039802062088000398020628800039802062

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. 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
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

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