Humelock II Cemented Reversible Shoulder

Basic Information

• Brand Name: Humelock II Cemented Reversible Shoulder
• Primary DI: 03701037301500
• Version / Model: 314-0703
• Catalog Number: 314-0703
• 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: 4
• Public Version Date: 2021-10-07
• Public Version Status: Update
• Public Device Record Key: bf536eba-efbc-4384-93d6-8b47c4741e18

Device Description

HUMERAL CUP 135/145° STANDARD PE/TA6V Ø40 +3

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
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	888.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48092	Polyethylene reverse shoulder prosthesis cup	A sterile component of a reverse shoulder prosthesis that consists of a polyethylene (PE) cup intended to be attached to a humeral stem prosthesis, or humeral body component, and to articulate with the reverse shoulder head.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03701037301500	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K150488	000

Device Sizes

Type	Value	Unit	Text
Height	3	Millimeter

Storage Conditions

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