TVP System (Vertebra Plasty SET B)

Basic Information

• Brand Name: TVP System (Vertebra Plasty SET B)
• Primary DI: 08809281659806
• Version / Model: TYP-TVPB
• Catalog Number: TYP-TVPB
• Company Name: Taeyeon Medical co.,Ltd.
• Labeler DUNS: 687607387
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-03
• Public Version: 1
• Public Version Date: 2025-09-11
• Public Version Status: New
• Public Device Record Key: 213fe62f-4805-47bd-9760-b5527fe013b1

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1
OCJ	Spinal Channeling Instrument, Vertebroplasty	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35809	Orthopaedic cement dispenser	A syringe-like device intended for use in placing orthopaedic bone cement into surgical sites. Cement dispensers may be manually-operated or mounted in a powered unit that drives the piston down the syringe barrel. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809281659806	GS1