Rim-Fix

FDA UDI

Class II (US FDA UDI)

by Implants International Ltd

Identity

Trade Name: Rim-Fix FDA UDI
Generic Name: Constrained polyethylene acetabular liner FDA UDI
Device Name: Poly Liner 10° Hood 60 x 28mm (UHMWPE) Uncemented FDA UDI
Model / Reference: Poly Liner 10° Hood 60 x 28mm FDA UDI
Description: Poly Liner 10° Hood 60 x 28mm (UHMWPE) Uncemented FDA UDI

Identifiers

Catalog Number: AL3772 FDA UDI
Primary DI / UDI-DI: 05051693308114 FDA UDI
510(k) Number: K993713 FDA UDI
FDA Product Code: JDI FDA UDI
GMDN Term: Constrained polyethylene acetabular liner 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 — 60 Millimeter FDA UDI

Category: Constrained polyethylene acetabular liner

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

Similar devices

Also classified as Constrained polyethylene acetabular liner.

Omnifit — Howmedica Osteonics Corp. · Class II
Trilogy® — Zimmer, Inc. · Class II
Trident — Howmedica Osteonics Corp. · Class II
System 12 — Howmedica Osteonics Corp. · Class II
Trabecular Metal® Acetabular Revision System — Zimmer, Inc. · Class II
Omnifit — Howmedica Osteonics Corp. · Class II
G7® Freedom® Vivacit-E® — Zimmer, Inc. · Class II
System 12 — Howmedica Osteonics Corp. · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Implants International Ltd

Sources (1)

FDA UDI 0733153b-286f-412d-80f1-43f9fa3d64ec 38 fields · synced Jun 8, 2026