Device
Atlas Humeral Nail System Cortical Locking Screw: Ø5mm x 030mm (non-sterile)
Manufacturer
Orthopedic Designs North America, Inc.
Orthopedic Designs North America, Inc.
Model: AHN5030NS
Catalog: AHN-5-030NS
DI: B058AHN5030NS1
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Description
Atlas Humeral Nail System Cortical Locking Screw: Ø5mm x 030mm (non-sterile)
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
535ae9b4-667a-4b0b-adc6-94e8dd62272d
Distribution Status:
In Commercial Distribution
DUNS Number:
945518848
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
B058AHN5030NS1
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 66947
Name: Orthopaedic bone screw (non-sliding)
Definition:
A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.
FDA Product Codes
HSB
Rod, Fixation, Intramedullary And Accessories
Premarket Submissions
Submission Number:
K241484
Supplement Number:
000
Device Sizes
Item #1 - Size - @attributes - Unit:
Millimeter
Item #1 - Size - @attributes - Value:
30
Item #1 - Size Type:
Length
Item #2 - Size - @attributes - Unit:
Millimeter
Item #2 - Size - @attributes - Value:
5
Item #2 - Size Type:
Outer Diameter