TVP System (Vertebra Plasty SET B) TYP-TVPB

GUDID 08809281659806

1) Vertebro puncture needle It includes instruments for puncturing living tissue, such as drills and reamers, and instruments used to enlarge the punctured area for inserting prostheses into bones. 2) Spacer: A device for injecting bone cement into the surgical site.

Taeyeon Medical co.,Ltd.

Orthopaedic cement dispenser

• Primary Device ID: 08809281659806
• NIH Device Record Key: 213fe62f-4805-47bd-9760-b5527fe013b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TVP System (Vertebra Plasty SET B)
• Version Model Number: TYP-TVPB
• Catalog Number: TYP-TVPB
• Company DUNS: 687607387
• Company Name: Taeyeon Medical co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809281659806 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-11
• Device Publish Date: 2025-09-03

Devices Manufactured by Taeyeon Medical co.,Ltd.

• 08809281659806 - TVP System (Vertebra Plasty SET B): 2025-09-111) Vertebro puncture needle It includes instruments for puncturing living tissue, such as drills and reamers, and instruments used to enlarge the punctured area for inserting prostheses into bones. 2) Spacer: A device for injecting bone cement into the surgical site.
• 08809281659806 - TVP System (Vertebra Plasty SET B): 2025-09-11 1) Vertebro puncture needle It includes instruments for puncturing living tissue, such as drills and reamers, and instruments u
• 08809281659301 - BALEX Bone Expander System: 2025-09-01 Kyphoplasty balloon catheter Definition: A sterile, flexible tube designed to be used for the creation of a void within a verteb
• 08809281659325 - BALEX Bone Expander System: 2025-09-01 Kyphoplasty balloon catheter Definition: A sterile, flexible tube designed to be used for the creation of a void within a verteb
• 08809281659370 - BALEX Bone Expander System: 2025-09-01 BALEX Bone Expander Systems are the device intended to insert the bone cement into the cavity made by the balloon tip in the fra
• 08809281659417 - PCD System: 2025-09-01 CEMENT DISPENSER SYSTEM (PCD) SET A