Humeris Shoulder

Basic Information

• Brand Name: Humeris Shoulder
• Primary DI: 03701037300565
• Version / Model: 106-3905
• Catalog Number: 106-3905
• Company Name: FX SOLUTIONS
• Labeler DUNS: 263076196
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-22
• Public Version: 4
• Public Version Date: 2021-10-07
• Public Version Status: Update
• Public Device Record Key: 8a98eb83-40bb-48f7-8118-4ccc976855cf

Device Description

CENTERED SPACER TA6V Ø39 +5 mm 0°

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	888.3690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60512	Shoulder humeral body prosthesis	A sterile implantable component of a total shoulder prosthesis intended to form a connection between a humeral stem prosthesis and a humeral head prosthesis. It is made of metal [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)] or titanium (Ti)] and is used in a modular shoulder replacement system.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03701037300565	GS1

Premarket Submissions

Submission Number	Supplement Number
K163669	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	39	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store away from light and sunlight Store away from moisture