Atlas™ Humeral Nail System

FDA UDI

Class II (US FDA UDI)

by Orthopedic Designs North America, Inc.

Identity

Trade Name: Atlas™ Humeral Nail System FDA UDI
Generic Name: Orthopaedic bone screw (non-sliding) FDA UDI
Device Name: Atlas Humeral Nail System - Atlas Screw Ø5mm x 040mm FDA UDI
Model / Reference: AS5040 FDA UDI
Description: Atlas Humeral Nail System - Atlas Screw Ø5mm x 040mm FDA UDI

Identifiers

Catalog Number: AS-5-040 FDA UDI
Primary DI / UDI-DI: B058AS50401 FDA UDI
510(k) Number: K241484 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Orthopaedic bone screw (non-sliding) 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 5 Millimeter FDA UDI
Length — 40 Millimeter FDA UDI

Category: Orthopaedic bone screw (non-sliding)

The Atlas Humeral Nail System is a high-quality, implantable orthopedic bone screw designed for internal fixation of fractures in the humerus, rib, sternum, and pelvis. This innovative device provides direct interfragmentary stabilization of fractured bones and offers a combination of stability, flexibility, and longevity.

Similar devices

Also classified as Orthopaedic bone screw (non-sliding).

EVOS — Smith & Nephew, Inc. · Class II
TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
Arthrex® — Arthrex, Inc. · Class II
Zavation — ZAVATION · Class II
STARDRIVE — Synthes GmbH · Class IIb
Arthrex® — Arthrex, Inc. · Class II
Cancellous Screw, Locking — I.T.S. GmbH · Class II
PANGEA — Stryker Corp. · Class II

Cleared under the same submission

K241484 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: Orthopedic Designs North America, Inc.

Sources (1)

FDA UDI beb0e7bc-c4b4-4034-9351-5f9f45e40958 37 fields · synced Jun 24, 2026