Fortis ACP TPL.PL.0379

GUDID 08800113935457

Fortis Extra Lordotic Plate Level3-(L2)79x(L1)86.8x(W)16mm-Gold

DIOMEDICAL CO.,LTD.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 08800113935457
• NIH Device Record Key: b172f9da-e9b3-4a28-ad0c-5081a314a092
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fortis ACP
• Version Model Number: A
• Catalog Number: TPL.PL.0379
• Company DUNS: 557795909
• Company Name: DIOMEDICAL CO.,LTD.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800113935457 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173099

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

[08800113935457]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-26
• Device Publish Date: 2021-03-18

On-Brand Devices [Fortis ACP]

• 08800039802048: Pre-set angle Drill Guide (single barrel) - like Uniplate
• 08800039802031: Variable angle Drill Guide (single barrel) - like Uniplate
• 08800039802017: Plate Holder
• 08800039870474: FORTIS 2.36mm Longer HEX Screwdriver
• 08800039868334: Fortis Temporary Fixation pin Long type
• 08800039834490: Fixed Angle Selftapping Rounded Screw 4.5 X 26
• 08800039834483: Fixed Angle Selftapping Rounded Screw 4.5 X 24
• 08800039834469: Fixed Angle Selftapping Rounded Screw 4.5 X 20
• 08800039834452: Fixed Angle Selftapping Rounded Screw 4.5 X 18
• 08800039834445: Fixed Angle Selftapping Rounded Screw 4.5 X 16
• 08800039834438: Fixed Angle Selftapping Rounded Screw 4.5 X 14
• 08800039834421: Fixed Angle Selftapping Rounded Screw 4.5 X 12
• 08800039834414: Fixed Angle Selftapping Rounded Screw 4.5 X 10
• 08800039834407: Fixed Angle Selftapping Rounded Screw 4.0 X 26
• 08800039834391: Fixed Angle Selftapping Rounded Screw 4.0 X 24
• 08800039834384: Fixed Angle Selftapping Rounded Screw 4.0 X 22
• 08800039834377: Fixed Angle Selftapping Rounded Screw 4.0 X 20
• 08800039834360: Fixed Angle Selftapping Rounded Screw 4.0 X 18
• 08800039834353: Fixed Angle Selftapping Rounded Screw 4.0 X 16
• 08800039834346: Fixed Angle Selftapping Rounded Screw 4.0 X 14
• 08800039834339: Fixed Angle Selftapping Rounded Screw 4.0 X 12
• 08800039834322: Fixed Angle Selftapping Rounded Screw 4.0 X 10
• 08800039834315: Variable Angle Selftapping Rounded Screw 4.5 X 26
• 08800039834308: Variable Angle Selftapping Rounded Screw 4.5 X 24
• 08800039834292: Variable Angle Selftapping Rounded Screw 4.5 X 22
• 08800039834285: Variable Angle Selftapping Rounded Screw 4.5 X 20
• 08800039834278: Variable Angle Selftapping Rounded Screw 4.5 X 18
• 08800039834261: Variable Angle Selftapping Rounded Screw 4.5 X 16
• 08800039834254: Variable Angle Selftapping Rounded Screw 4.5 X 14
• 08800039834247: Variable Angle Selftapping Rounded Screw 4.5 X 12
• 08800039834230: Variable Angle Selftapping Rounded Screw 4.5 X 10
• 08800039834223: Variable Angle Selftapping Rounded Screw 4.0 X 26
• 08800039834216: Variable Angle Selftapping Rounded Screw 4.0 X 24
• 08800039834209: Variable Angle Selftapping Rounded Screw 4.0 X 22
• 08800039834193: Variable Angle Selftapping Rounded Screw 4.0 X 20
• 08800039834186: Variable Angle Selftapping Rounded Screw 4.0 X 18
• 08800039834179: Variable Angle Selftapping Rounded Screw 4.0 X 16
• 08800039834162: Variable Angle Selftapping Rounded Screw 4.0 X 14
• 08800039834155: Variable Angle Selftapping Rounded Screw 4.0 X 12
• 08800039834148: Variable Angle Selftapping Rounded Screw 4.0 X 10
• 08800039830935: EXTENDED FORTIS DRILL
• 08800039830928: EXTENDED FORTIS DRILL
• 08800039830911: EXTENDED FORTIS DRILL
• 08800039830904: EXTENDED FORTIS DRILL
• 08800039830898: EXTENDED FORTIS AWL
• 08800039830553: Fortis self Ramp driver
• 08800039830546: Tapered Fortis self retaining driver
• 08800039829977: DRIVING HANDLE SHORT A-O TYPE
• 08800039825535: 2.38mm HEX DRIVER SHORT TYPE
• 08800039825528: SCREW DRIVER 2.3mm HEX ONE BODY