Shoulder System

Basic Information

• Brand Name: Shoulder System
• Primary DI: 07630542714740
• Version / Model: 04.01.0412
• Company Name: Medacta International SA
• Labeler DUNS: 488227125
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-13
• Public Version: 1
• Public Version Date: 2023-11-21
• Public Version Status: New
• Public Device Record Key: 76a4058a-46fa-44c4-b8a7-0ea255eb5d2f

Device Description

GRS baseplate 27 30 Full wedge 10

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

GMDN Terms

Code	Name	Definition	Implantable	Status
35670	Total shoulder prosthesis	A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07630542714740	GS1

Premarket Submissions

Submission Number	Supplement Number
K231911	000