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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
Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Device Name
4.5 Locking Screw, 47.5mm FDA UDI
Model / Reference
SO02-3008-47.5 FDA UDI
Description
4.5 Locking Screw, 47.5mm FDA UDI

Identifiers

Catalog Number
SO02-3008-47.5 FDA UDI
Primary DI / UDI-DI
00815482020701 FDA UDI
FDA Product Code
HWC FDA UDI
HRS FDA UDI
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
888.3030 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 47.5 Millimeter FDA UDI

Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile

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

Similar devices

Also classified as Orthopaedic bone screw, non-bioabsorbable, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shoulder Options, Inc.

Sources (1)

  • FDA UDI 818b3919-2f78-439e-b589-9d1c4bb7f4c5 36 fields · synced Jun 8, 2026