GTFx™ Greater Tuberosity Fracture Plate System

FDA UDI

Class II (US FDA UDI)

by Shoulder Options, Inc.

Identity

Trade Name: GTFx™ Greater Tuberosity Fracture Plate System FDA UDI
Generic Name: Orthopaedic instrument surgical connector FDA UDI
Device Name: GTF Guide Handle FDA UDI
Model / Reference: SO03-3152 FDA UDI
Description: GTF Guide Handle FDA UDI

Identifiers

Catalog Number: SO03-3152 FDA UDI
Primary DI / UDI-DI: 00815482021012 FDA UDI
FDA Product Code: HRS FDA UDI
HWC FDA UDI
GMDN Term: Orthopaedic instrument surgical connector FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
888.3040 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic instrument surgical connector

GTFx™ Greater Tuberosity Fracture Plate System by Shoulder Options, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
Pilot Spinal System — Life Spine, Inc. · Class II
MIS Curved Rod, Ø5.5 x 85mm — Captiva Spine · 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 II	Pending data

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Manufacturer

Manufacturer: Shoulder Options, Inc.

Sources (1)

FDA UDI 46cc33db-13c0-44ab-8cd3-e2ac723d30a4 35 fields · synced May 31, 2026