LOSPA IS Spinal Instrument

GUDID 08800017278506

ANTI TORQUE WRENCH

Corentec Co., Ltd

External spinal fixation system

• Primary Device ID: 08800017278506
• NIH Device Record Key: 4ebd60e3-3065-4f38-a327-243751835293
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOSPA IS Spinal Instrument
• Version Model Number: SI.AP6.0032
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800017278506 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200267

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[08800017278506]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-17
• Device Publish Date: 2020-04-09

Devices Manufactured by Corentec Co., Ltd

• 08800017219097 - LOSPA IS Spinal System: 2024-07-22 ACP Variable Screw, Self-Tapping (Non-sterile)
• 08800017219103 - LOSPA IS Spinal System: 2024-07-22 ACP Variable Screw, Self-Tapping (Non-sterile)
• 08800017219110 - LOSPA IS Spinal System: 2024-07-22 ACP Variable Screw, Self-Tapping (Non-sterile)
• 08800017219127 - LOSPA IS Spinal System: 2024-07-22 ACP Variable Screw, Self-Tapping (Non-sterile)
• 08800017219134 - LOSPA IS Spinal System: 2024-07-22 ACP Variable Screw, Self-Tapping (Non-sterile)
• 08800017219141 - LOSPA IS Spinal System: 2024-07-22 ACP Variable Screw, Self-Tapping (Non-sterile)
• 08800017219158 - LOSPA IS Spinal System: 2024-07-22 ACP Variable Screw, Self-Tapping (Non-sterile)
• 08800017219165 - LOSPA IS Spinal System: 2024-07-22 ACP Variable Screw, Self-Tapping (Non-sterile)