BENCOX Hip System

FDA UDI

Class II (US FDA UDI)

by Corentec Co., Ltd

Identity

Trade Name: BENCOX Hip System FDA UDI
Generic Name: Femoral stem centralizer FDA UDI
Device Name: Deformabla Centralizer 16mm (for No .2.5) FDA UDI
Model / Reference: H1.C11.0002 FDA UDI
Description: Deformabla Centralizer 16mm (for No .2.5) FDA UDI

Identifiers

Primary DI / UDI-DI: 08806373852466 FDA UDI
510(k) Number: K152084 FDA UDI
FDA Product Code: JDI FDA UDI
KWY FDA UDI
LZO FDA UDI
GMDN Term: Femoral stem centralizer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3350 FDA UDI
888.3390 FDA UDI
888.3353 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Femoral stem centralizer

BENCOX Hip System by Corentec Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Femoral stem centralizer.

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CPCS — Smith & Nephew, Inc. · Class II
CEMENTRALIZER — DEPUY ORTHOPAEDICS, INC. · Class II
INVIS — Smith & Nephew, Inc. · Class II
Ti Repicci II® Knee System — Biomet Orthopedics, Inc. · Class II
AESCULAP — AESCULAP, INC. · Class II
INVIS — Smith & Nephew, Inc. · Class II

Cleared under the same submission

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 II	Pending data

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Manufacturer

Manufacturer: Corentec Co., Ltd

Sources (1)

FDA UDI 229e9ba2-2f4f-4040-8d2b-dd84d5bf0524 35 fields · synced May 31, 2026