AFT™ Proximal Humerus Fracture Plate System

FDA UDI

Class II (US FDA UDI)

by Shoulder Options, Inc.

Identity

Trade Name: AFT™ Proximal Humerus Fracture Plate System FDA UDI
Generic Name: Manual surgical rotary handpiece, reusable FDA UDI
Device Name: 4.5mm QC/AO Ratcheting Handle FDA UDI
Model / Reference: SO02-3081 FDA UDI
Description: 4.5mm QC/AO Ratcheting Handle FDA UDI

Identifiers

Catalog Number: SO02-3081 FDA UDI
Primary DI / UDI-DI: 00815482020916 FDA UDI
FDA Product Code: HRS FDA UDI
HWC FDA UDI
GMDN Term: Manual surgical rotary handpiece, reusable 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: Manual surgical rotary handpiece, reusable

AFT™ Proximal Humerus Fracture Plate System by Shoulder Options, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 e90427d7-085b-474d-ab92-3d33897a5bb1 35 fields · synced May 30, 2026