LOSPA IS Spinal Fixation System

GUDID 08800017255613

POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø7.5 X 140, Length 28.2mm

Corentec Co., Ltd

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08800017255613
• NIH Device Record Key: 006ac794-ae51-4995-b003-011f626c2a0f
• Commercial Distribution Discontinuation: 2020-03-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: LOSPA IS Spinal Fixation System
• Version Model Number: SA.228.7518
• Company DUNS: 688739895
• Company Name: Corentec Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800017255613 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200267

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

[08800017255613]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-24
• Device Publish Date: 2020-03-16

On-Brand Devices [LOSPA IS Spinal Fixation System]

• 08800017249490: POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 75, Length 15.5mm
• 08800017249483: POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 70, Length 15.5mm
• 08800017249476: POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 65, Length 15.5mm
• 08800017249469: POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 60, Length 15.5mm
• 08800017249452: POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 55, Length 15.5mm
• 08800017249445: POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 50, Length 15.5mm
• 08800017249438: POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 45, Length 15.5mm
• 08800017249421: POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 40, Length 15.5mm
• 08800017249414: POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 35, Length 15.5mm
• 08800017249407: POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 30, Length 15.5mm
• 08800017249391: POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 25, Length 15.5mm
• 08800017249384: POLYAXIAL PEDICLE SCREW II - standard type Ø5.5 X 55, Length 15.5mm
• 08800017249377: POLYAXIAL PEDICLE SCREW II - standard type Ø5.5 X 50, Length 15.5mm
• 08800017249360: POLYAXIAL PEDICLE SCREW II - standard type Ø5.5 X 45, Length 15.5mm
• 08800017249353: POLYAXIAL PEDICLE SCREW II - standard type Ø5.5 X 40, Length 15.5mm
• 08800017249346: POLYAXIAL PEDICLE SCREW II - standard type Ø5.5 X 35, Length 15.5mm
• 08800017249339: POLYAXIAL PEDICLE SCREW II - standard type Ø5.5 X 30, Length 15.5mm
• 08800017249322: POLYAXIAL PEDICLE SCREW II - standard type Ø5.5 X 25, Length 15.5mm
• 08800017249315: POLYAXIAL PEDICLE SCREW II - standard type Ø5.5 X 20, Length 15.5mm
• 08800017249308: POLYAXIAL PEDICLE SCREW II - standard type Ø5.0 X 55, Length 15.5mm
• 08800017249292: POLYAXIAL PEDICLE SCREW II - standard type Ø5.0 X 50, Length 15.5mm
• 08800017249285: POLYAXIAL PEDICLE SCREW II - standard type Ø5.0 X 45, Length 15.5mm
• 08800017249278: POLYAXIAL PEDICLE SCREW II - standard type Ø5.0 X 40, Length 15.5mm
• 08800017249261: POLYAXIAL PEDICLE SCREW II - standard type Ø5.0 X 35, Length 15.5mm
• 08800017249254: POLYAXIAL PEDICLE SCREW II - standard type Ø5.0 X 30, Length 15.5mm
• 08800017249247: POLYAXIAL PEDICLE SCREW II - standard type Ø5.0 X 25, Length 15.5mm
• 08800017249230: POLYAXIAL PEDICLE SCREW II - standard type Ø5.0 X 20, Length 15.5mm
• 08800017249223: POLYAXIAL PEDICLE SCREW II - standard type Ø4.5 X 55, Length 15.5mm
• 08800017249216: POLYAXIAL PEDICLE SCREW II - standard type Ø4.5 X 50, Length 15.5mm
• 08800017249209: POLYAXIAL PEDICLE SCREW II - standard type Ø4.5 X 45, Length 15.5mm
• 08800017249193: POLYAXIAL PEDICLE SCREW II - standard type Ø4.5 X 40, Length 15.5mm
• 08800017249186: POLYAXIAL PEDICLE SCREW II - standard type Ø4.5 X 35, Length 15.5mm
• 08800017249179: POLYAXIAL PEDICLE SCREW II - standard type Ø4.5 X 30, Length 15.5mm
• 08800017249162: POLYAXIAL PEDICLE SCREW II - standard type Ø4.5 X 25, Length 15.5mm
• 08800017249155: POLYAXIAL PEDICLE SCREW II - standard type Ø4.5 X 20, Length 15.5mm
• 08800017249148: POLYAXIAL PEDICLE SCREW II - standard type Ø4.0 X 55, Length 15.5mm
• 08800017259086: POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 140, Length 28.2mm
• 08800017259079: POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 135, Length 28.2mm
• 08800017259062: POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 130, Length 28.2mm
• 08800017259055: POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 125, Length 28.2mm
• 08800017259048: POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 120, Length 28.2mm
• 08800017259031: POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 115, Length 28.2mm
• 08800017259024: POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 110, Length 28.2mm
• 08800017259017: POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 105, Length 28.2mm
• 08800017259000: POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 100, Length 28.2mm
• 08800017258997: POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 95, Length 28.2mm
• 08800017258980: POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 90, Length 28.2mm
• 08800017258973: POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 85, Length 28.2mm
• 08800017258966: POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 80, Length 28.2mm
• 08800017258959: POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 75, Length 28.2mm