Multiloc

FDA UDI

Class II (US FDA UDI)

by Synthes

Identity

Trade Name: MULTILOC FDA UDI
Generic Name: Orthopaedic bone-reduction tool FDA UDI
Device Name: REDUCTION INSTRUMENT FOR MULTILOC HUMERAL NAIL/330MM FDA UDI
Model / Reference: 03.019.011 FDA UDI
Description: REDUCTION INSTRUMENT FOR MULTILOC HUMERAL NAIL/330MM FDA UDI

Identifiers

Catalog Number: 03019011 FDA UDI
Primary DI / UDI-DI: 10886982069481 FDA UDI
510(k) Number: K120807 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Orthopaedic bone-reduction tool FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3020 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: Orthopaedic bone-reduction tool

Multiloc by Synthes — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone-reduction tool.

TRIGEN MAX — Smith & Nephew, Inc. · Class II
REDUCTION TOOL SMALL BONE NAIL — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
Tools - WFS (C) — Trimed, INC. · Class I
TRIGEN — Smith & Nephew, Inc. · Class II
PRECICE® Trauma Nail System — NuVasive Specialized Orthopedics, Inc. · Class I
Reduction Rod — Double Medical Technology Inc. · Class II
TRIGEN — Smith & Nephew, Inc. · Class II
CENTRONAIL TITANIUM UNIVERSAL FEMORAL NAILING SYSTEM — Orthofix, Inc. · Class II

Cleared under the same submission

K120807 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: Synthes

Sources (1)

FDA UDI 0721dd3c-0f2d-47c3-a852-cfdfcdcc90bb 36 fields · synced May 31, 2026