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BENCOX Hip System

FDA UDI

Class II (US FDA UDI)

by Corentec Co., Ltd

Identity

Trade Name
BENCOX Hip System FDA UDI
Generic Name
Polymer orthopaedic cement restrictor, non-bioabsorbable FDA UDI
Device Name
BONE PLUG 13mm FDA UDI
Model / Reference
01.05.413 FDA UDI
Description
BONE PLUG 13mm FDA UDI

Identifiers

Primary DI / UDI-DI
08806373833090 FDA UDI
510(k) Number
K152084 FDA UDI
FDA Product Code
JDI FDA UDI
KWY FDA UDI
LZO FDA UDI
GMDN Term
Polymer orthopaedic cement restrictor, non-bioabsorbable 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

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Polymer orthopaedic cement restrictor, non-bioabsorbable

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

Similar devices

Also classified as Polymer orthopaedic cement restrictor, non-bioabsorbable.

Cleared under the same submission

K152084 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Corentec Co., Ltd

Sources (1)

  • FDA UDI 2b9984ae-ee45-4d3d-9f1f-5e5821b152c7 35 fields · synced Jun 8, 2026