Rim-Fix

FDA UDI

Class II (US FDA UDI)

by Implants International Ltd

Identity

Trade Name: Rim-Fix FDA UDI
Generic Name: Acetabular shell FDA UDI
Device Name: ACETABULAR DUAL COATED CUP UNCEMENTED -46mm (DUAL COATED) FOR UNCEMENTED APPLICATIONS FDA UDI
Model / Reference: DUAL COATED CUP - UNCEMENTED -46mm FDA UDI
Description: ACETABULAR DUAL COATED CUP UNCEMENTED -46mm (DUAL COATED) FOR UNCEMENTED APPLICATIONS FDA UDI

Identifiers

Catalog Number: AS4012 FDA UDI
Primary DI / UDI-DI: 05051693309715 FDA UDI
510(k) Number: K993713 FDA UDI
FDA Product Code: JDI FDA UDI
GMDN Term: Acetabular shell FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3350 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

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 46 Millimeter FDA UDI

Category: Acetabular shell

Rim-Fix by Implants International Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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REFLECTION — Smith & Nephew, Inc. · Class II
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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: Implants International Ltd

Sources (1)

FDA UDI a06c21ee-62ef-4625-ac3e-b056f81e68ad 38 fields · synced Jun 6, 2026