LOSPA & LOSPA IS Spinal System

GUDID 08806373855009

LOSPA IS T-PLIF Cage(Non-sterile)

Corentec Co., Ltd

Polymeric spinal interbody fusion cage

• Primary Device ID: 08806373855009
• NIH Device Record Key: 589fa4ec-e89c-419e-b4bb-82f73fcf9d0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOSPA & LOSPA IS Spinal System
• Version Model Number: SC.B08.2813
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806373855009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151408

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[08806373855009]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-10-28

On-Brand Devices [LOSPA & LOSPA IS Spinal System]

• 08806373858055: LOSPA IS ACIF Cage(Non-sterile)
• 08806373858048: LOSPA IS ACIF Cage(Non-sterile)
• 08806373858031: LOSPA IS ACIF Cage(Non-sterile)
• 08806373858024: LOSPA IS ACIF Cage(Non-sterile)
• 08806373858017: LOSPA IS ACIF Cage(Non-sterile)
• 08806373858000: LOSPA IS ACIF Cage(Non-sterile)
• 08806373857997: LOSPA IS ACIF Cage(Non-sterile)
• 08806373857980: LOSPA IS ACIF Cage(Non-sterile)
• 08806373857973: LOSPA IS ACIF Cage(Non-sterile)
• 08806373857966: LOSPA IS ACIF Cage(Non-sterile)
• 08806373857959: LOSPA IS ACIF Cage(Non-sterile)
• 08806373857942: LOSPA IS ACIF Cage(Non-sterile)
• 08806373857935: LOSPA IS ACIF Cage(Non-sterile)
• 08806373857928: LOSPA IS ACIF Cage(Non-sterile)
• 08806373857911: LOSPA IS ACIF Cage(Non-sterile)
• 08806373857904: LOSPA IS ACIF Cage(Non-sterile)
• 08806373857898: LOSPA IS ACIF Cage(Non-sterile)
• 08806373857881: LOSPA IS ACIF Cage(Non-sterile)
• 08806373857874: LOSPA IS ACIF Cage(Non-sterile)
• 08806373857867: LOSPA IS ACIF Cage(Non-sterile)
• 08806373857850: LOSPA IS ACIF Cage(Non-sterile)
• 08806373857843: LOSPA IS ACIF Cage(Non-sterile)
• 08806373857836: LOSPA IS ACIF Cage(Non-sterile)
• 08806373857829: LOSPA IS ACIF Cage(Non-sterile)
• 08806373857256: LOSPA IS ALIF Cage(Non-sterile)
• 08806373857249: LOSPA IS ALIF Cage(Non-sterile)
• 08806373857232: LOSPA IS ALIF Cage(Non-sterile)
• 08806373857225: LOSPA IS ALIF Cage(Non-sterile)
• 08806373857218: LOSPA IS ALIF Cage(Non-sterile)
• 08806373857201: LOSPA IS ALIF Cage(Non-sterile)
• 08806373857195: LOSPA IS ALIF Cage(Non-sterile)
• 08806373857188: LOSPA IS ALIF Cage(Non-sterile)
• 08806373857171: LOSPA IS ALIF Cage(Non-sterile)
• 08806373857164: LOSPA IS ALIF Cage(Non-sterile)
• 08806373857157: LOSPA IS ALIF Cage(Non-sterile)
• 08806373857140: LOSPA IS ALIF Cage(Non-sterile)
• 08806373857133: LOSPA IS ALIF Cage(Non-sterile)
• 08806373857126: LOSPA IS ALIF Cage(Non-sterile)
• 08806373857119: LOSPA IS ALIF Cage(Non-sterile)
• 08806373857102: LOSPA IS ALIF Cage(Non-sterile)
• 08806373857096: LOSPA IS ALIF Cage(Non-sterile)
• 08806373857089: LOSPA IS ALIF Cage(Non-sterile)
• 08806373857072: LOSPA IS ALIF Cage(Non-sterile)
• 08806373857065: LOSPA IS ALIF Cage(Non-sterile)
• 08806373857058: LOSPA IS ALIF Cage(Non-sterile)
• 08806373857041: LOSPA IS ALIF Cage(Non-sterile)
• 08806373857034: LOSPA IS ALIF Cage(Non-sterile)
• 08806373857027: LOSPA IS ALIF Cage(Non-sterile)
• 08806373857010: LOSPA IS ALIF Cage(Non-sterile)
• 08806373857003: LOSPA IS ALIF Cage(Non-sterile)