Proximal Humeral Fracture Plate System

FDA UDI

Class I (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: Proximal Humeral Fracture Plate System FDA UDI
Generic Name: Orthopaedic implant aiming arm FDA UDI
Device Name: GREATER TUBEROSITY HUMERAL FRACTURE PLATE TARGET FDA UDI
Model / Reference: HTG-0930-03R FDA UDI
Description: GREATER TUBEROSITY HUMERAL FRACTURE PLATE TARGET FDA UDI

Identifiers

Catalog Number: HTG-0930-03R FDA UDI
Primary DI / UDI-DI: 00885556829912 FDA UDI
FDA Product Code: FZX FDA UDI
GMDN Term: Orthopaedic implant aiming arm FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

Yes

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 implant aiming arm

Proximal Humeral Fracture Plate System by Smith & Nephew, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic implant aiming arm.

ANTEGRADE TARGETING MODULE FEMORAL NAIL SYSTEM — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
TARGETING ARM — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
Dyna Locking Trochanteric Nail — CG MedTech Co., Ltd. · Class I
ANTEGRADE FEMORAL NAIL DRIVER — Biomet Orthopedics, Inc. · Class I
Jig — I.T.S. GmbH · Class I
Piccolo Composite Plate System — CARBOFIX ORTHOPEDICS LTD · Class II
MALLORY HEAD — Biomet Orthopedics, Inc. · Class I
Piccolo Composite Plate System — CARBOFIX ORTHOPEDICS LTD · Class II

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 I	Pending data

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

Manufacturer

Manufacturer: Smith & Nephew, Inc.

Sources (1)

FDA UDI d7780d3d-ac1e-4c14-88b5-2e941fe7ccda 35 fields · synced Jun 8, 2026