Corin Bipolar Prosthesis

FDA UDI

Class II (US FDA UDI)

by Corin Ltd

Identity

Trade Name: Corin Bipolar Prosthesis FDA UDI
Generic Name: Femoral head prosthesis trial FDA UDI
Device Name: BIPOLAR EUROCONE TRIAL HEAD 60mm SHORT FDA UDI
Model / Reference: E211.760 FDA UDI
Description: BIPOLAR EUROCONE TRIAL HEAD 60mm SHORT FDA UDI

Identifiers

Catalog Number: E211.760 FDA UDI
Primary DI / UDI-DI: 05055196948204 FDA UDI
510(k) Number: K925897 FDA UDI
FDA Product Code: KWY FDA UDI
GMDN Term: Femoral head prosthesis trial FDA UDI

Classification

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

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Femoral head prosthesis trial

The Corin Bipolar Prosthesis is a high-quality, reusable femoral head prosthesis designed for trial reductions during hip arthroplasty. It is typically made of metal or polymer material and includes trial adapters used with large trial heads. This device has undergone rigorous testing and validation to ensure its accuracy and precision.

Similar devices

Also classified as Femoral head prosthesis trial.

BI-METRIC(R) HEAD/NECK PROVISIONAL — Biomet Orthopedics, Inc. · Class I
Modal Total Hip System — MODAL MANUFACTURING LLC · Class II
CHARNLEY — DEPUY INTERNATIONAL LTD · Class I
Klassic Femoral Head Trial — TOTAL JOINT ORTHOPEDICS, INC. · Class I
AcuMatch — Exactech, Inc. · Class I
G7® — Biomet Orthopedics, Inc. · Class II
AcuMatch — Exactech, Inc. · Class I
NovoHip Total Hip System — Novosource, 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: Corin Ltd

Sources (1)

FDA UDI a4ef2eda-b14a-494c-9578-d20a5dcdbbf3 36 fields · synced Jun 24, 2026