CoCr Modular Head extra short

FDA UDI

Class II (US FDA UDI)

by Corin Ltd

Identity

Trade Name: CoCr Modular Head extra short FDA UDI
Generic Name: Metallic femoral head prosthesis FDA UDI
Device Name: Trinity CoCrMo Modular Head 36mm EXTRA SHORT -8.0mm FDA UDI
Model / Reference: E321.436 FDA UDI
Description: Trinity CoCrMo Modular Head 36mm EXTRA SHORT -8.0mm FDA UDI

Identifiers

Catalog Number: E321.436 FDA UDI
Primary DI / UDI-DI: 05055343885109 FDA UDI
510(k) Number: K131647 FDA UDI
FDA Product Code: LZO FDA UDI
MEH FDA UDI
GMDN Term: Metallic femoral head prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

Sterilization Method

Radiation Sterilization FDA UDI

Category: Metallic femoral head prosthesis

CoCr Modular Head extra short by Corin Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Metallic femoral head prosthesis.

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A110212031 — EUROS SAS · Class III
Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
BIOMET HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
Femoral Head — SIGNATURE ORTHOPAEDICS PTY LTD · Class II

Cleared under the same submission

K131647 also covers:

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 62ef69ad-03b8-4e17-b322-66a09890728f 36 fields · synced May 30, 2026