Fortis ACP TP.FD.4512

GUDID 08800039801775

Fixed-angle screws (self-drilling) D4.5 x L12

DIOMEDICAL CO.,LTD.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable
Primary Device ID08800039801775
NIH Device Record Key7917e792-ef4a-4a8a-bce2-df8558f3b605
Commercial Distribution StatusIn Commercial Distribution
Brand NameFortis ACP
Version Model NumberA
Catalog NumberTP.FD.4512
Company DUNS557795909
Company NameDIOMEDICAL CO.,LTD.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108800039801775 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800039801775]

Moist Heat or Steam Sterilization

[08800039801775]

Moist Heat or Steam Sterilization

[08800039801775]

Moist Heat or Steam Sterilization

[08800039801775]

Moist Heat or Steam Sterilization

[08800039801775]

Moist Heat or Steam Sterilization

[08800039801775]

Moist Heat or Steam Sterilization

[08800039801775]

Moist Heat or Steam Sterilization

[08800039801775]

Moist Heat or Steam Sterilization

[08800039801775]

Moist Heat or Steam Sterilization

[08800039801775]

Moist Heat or Steam Sterilization

[08800039801775]

Moist Heat or Steam Sterilization

[08800039801775]

Moist Heat or Steam Sterilization

[08800039801775]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-18
Device Publish Date2019-02-08

On-Brand Devices [Fortis ACP]

08800039802048Pre-set angle Drill Guide (single barrel) - like Uniplate
08800039802031Variable angle Drill Guide (single barrel) - like Uniplate
08800039802017Plate Holder
08800039870474FORTIS 2.36mm Longer HEX Screwdriver
08800039868334Fortis Temporary Fixation pin Long type
08800039834490Fixed Angle Selftapping Rounded Screw 4.5 X 26
08800039834483Fixed Angle Selftapping Rounded Screw 4.5 X 24
08800039834469Fixed Angle Selftapping Rounded Screw 4.5 X 20
08800039834452Fixed Angle Selftapping Rounded Screw 4.5 X 18
08800039834445Fixed Angle Selftapping Rounded Screw 4.5 X 16
08800039834438Fixed Angle Selftapping Rounded Screw 4.5 X 14
08800039834421Fixed Angle Selftapping Rounded Screw 4.5 X 12
08800039834414Fixed Angle Selftapping Rounded Screw 4.5 X 10
08800039834407Fixed Angle Selftapping Rounded Screw 4.0 X 26
08800039834391Fixed Angle Selftapping Rounded Screw 4.0 X 24
08800039834384Fixed Angle Selftapping Rounded Screw 4.0 X 22
08800039834377Fixed Angle Selftapping Rounded Screw 4.0 X 20
08800039834360Fixed Angle Selftapping Rounded Screw 4.0 X 18
08800039834353Fixed Angle Selftapping Rounded Screw 4.0 X 16
08800039834346Fixed Angle Selftapping Rounded Screw 4.0 X 14
08800039834339Fixed Angle Selftapping Rounded Screw 4.0 X 12
08800039834322Fixed Angle Selftapping Rounded Screw 4.0 X 10
08800039834315Variable Angle Selftapping Rounded Screw 4.5 X 26
08800039834308Variable Angle Selftapping Rounded Screw 4.5 X 24
08800039834292Variable Angle Selftapping Rounded Screw 4.5 X 22
08800039834285Variable Angle Selftapping Rounded Screw 4.5 X 20
08800039834278Variable Angle Selftapping Rounded Screw 4.5 X 18
08800039834261Variable Angle Selftapping Rounded Screw 4.5 X 16
08800039834254Variable Angle Selftapping Rounded Screw 4.5 X 14
08800039834247Variable Angle Selftapping Rounded Screw 4.5 X 12
08800039834230Variable Angle Selftapping Rounded Screw 4.5 X 10
08800039834223Variable Angle Selftapping Rounded Screw 4.0 X 26
08800039834216Variable Angle Selftapping Rounded Screw 4.0 X 24
08800039834209Variable Angle Selftapping Rounded Screw 4.0 X 22
08800039834193Variable Angle Selftapping Rounded Screw 4.0 X 20
08800039834186Variable Angle Selftapping Rounded Screw 4.0 X 18
08800039834179Variable Angle Selftapping Rounded Screw 4.0 X 16
08800039834162Variable Angle Selftapping Rounded Screw 4.0 X 14
08800039834155Variable Angle Selftapping Rounded Screw 4.0 X 12
08800039834148Variable Angle Selftapping Rounded Screw 4.0 X 10
08800039830935EXTENDED FORTIS DRILL
08800039830928EXTENDED FORTIS DRILL
08800039830911EXTENDED FORTIS DRILL
08800039830904EXTENDED FORTIS DRILL
08800039830898EXTENDED FORTIS AWL
08800039830553Fortis self Ramp driver
08800039830546Tapered Fortis self retaining driver
08800039829977DRIVING HANDLE SHORT A-O TYPE
088000398255352.38mm HEX DRIVER SHORT TYPE
08800039825528SCREW DRIVER 2.3mm HEX ONE BODY
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