Humelock Reversed Shoulder

Basic Information

• Brand Name: Humelock Reversed Shoulder
• Primary DI: 03701037302309
• Version / Model: 312-0000
• Catalog Number: 312-0000
• Company Name: FX SOLUTIONS
• Labeler DUNS: 263076196
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-31
• Public Version: 4
• Public Version Date: 2021-10-08
• Public Version Status: Update
• Public Device Record Key: bd96741b-c76c-45d1-a43b-a79cf0a2e9ad

Device Description

HUMELOCK REVERSED SPOILER TA6V

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: 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
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	888.3690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60933	Humeral body extension prosthesis	A sterile implantable component of a reverse shoulder prosthesis that consists of a metal [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)] piece intended to function as a spacer between a reverse shoulder body prosthesis and a reverse shoulder cup prosthesis.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03701037302309	GS1

Premarket Submissions

Submission Number	Supplement Number
K162455	000