Humelock II Cementless Shoulder System

Basic Information

• Brand Name: Humelock II Cementless Shoulder System
• Primary DI: 03701037301982
• Version / Model: 107-4530
• Catalog Number: 107-4530
• Company Name: FX SOLUTIONS
• Labeler DUNS: 263076196
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-09
• Public Version: 5
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: c1b547ff-5891-44ee-aed6-12b96b836cf9

Device Description

CORTICAL SCREW TA6V Ø4.5mm L.30mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
48094	Shoulder prosthesis screw	A sterile screw or set of screws intended for implantable shoulder prosthesis assembly and/or fixation.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03701037301982	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K130759	000

Device Sizes

Type	Value	Unit	Text
Length	30	Millimeter

Storage Conditions

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