TVP System (Vertebra Plasty SET B)

FDA UDI

Class I (US FDA UDI)

by Taeyeon Medical Co., Ltd.

Identity

Trade Name: TVP System (Vertebra Plasty SET B) FDA UDI
Generic Name: Orthopaedic cement dispenser FDA UDI
Device Name: 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. FDA UDI
Model / Reference: TYP-TVPB FDA UDI
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. FDA UDI

Identifiers

Catalog Number: TYP-TVPB FDA UDI
Primary DI / UDI-DI: 08809281659806 FDA UDI
FDA Product Code: LXH FDA UDI
OCJ FDA UDI
GMDN Term: Orthopaedic cement dispenser FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthopaedic cement dispenser

TVP System (Vertebra Plasty SET B) by Taeyeon Medical Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Taeyeon Medical Co., Ltd.

Sources (1)

FDA UDI 213fe62f-4805-47bd-9760-b5527fe013b1 34 fields · synced May 30, 2026