LOSPA IS Spinal System

GUDID 08800017218953

LOSPA IS ACP RST 3 Level (Non-sterile)

Corentec 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 ID: 08800017218953
• NIH Device Record Key: 4f1f3e6a-12d7-4c1d-8b22-5ced5057c01e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOSPA IS Spinal System
• Version Model Number: SM.C03.0780
• 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: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800017218953 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161641

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[08800017218953]

Moist Heat or Steam Sterilization

[08800017218953]

Moist Heat or Steam Sterilization

[08800017218953]

Moist Heat or Steam Sterilization

[08800017218953]

Moist Heat or Steam Sterilization

[08800017218953]

Moist Heat or Steam Sterilization

[08800017218953]

Moist Heat or Steam Sterilization

[08800017218953]

Moist Heat or Steam Sterilization

[08800017218953]

Moist Heat or Steam Sterilization

[08800017218953]

Moist Heat or Steam Sterilization

[08800017218953]

Moist Heat or Steam Sterilization

[08800017218953]

Moist Heat or Steam Sterilization

[08800017218953]

Moist Heat or Steam Sterilization

[08800017218953]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-18
• Device Publish Date: 2017-04-06

On-Brand Devices [LOSPA IS Spinal System]

• 08800017222936: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222929: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222912: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222905: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222899: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222882: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222875: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222868: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222851: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222844: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222837: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222820: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222813: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222806: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222790: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222783: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222776: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222769: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222752: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222745: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222738: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222721: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222714: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222707: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222691: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222684: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222677: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222660: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222653: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222646: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222639: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222622: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222615: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222608: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222592: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222585: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222578: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222561: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222554: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222547: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222530: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222523: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222516: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222509: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222493: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222486: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222479: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222462: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222455: LOSPA IS DLIF Cage (Non-sterile)
• 08800017222448: LOSPA IS DLIF Cage (Non-sterile)