R3

FDA UDI

Class III (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: R3 FDA UDI
Generic Name: Femoral head prosthesis trial FDA UDI
Device Name: MODIFIED -3MM OFFSET TRIAL HEAD SZ36MM FDA UDI
Model / Reference: E0015118-5 FDA UDI
Description: MODIFIED -3MM OFFSET TRIAL HEAD SZ36MM FDA UDI

Identifiers

Catalog Number: E0015118-5 FDA UDI
Primary DI / UDI-DI: 00885556653395 FDA UDI
510(k) Number: K132435 FDA UDI
FDA Product Code: LPO FDA UDI
GMDN Term: Femoral head prosthesis trial FDA UDI

Classification

Device Class: Class III FDA UDI
Regulation Number: 886.4270 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

R3 by Smith & Nephew, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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

K132435 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 III	Pending data

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

Manufacturer

Manufacturer: Smith & Nephew, Inc.

Sources (1)

FDA UDI 2207133f-afad-46af-9fa9-3d49d8753e22 36 fields · synced Jun 8, 2026