FREEDOM STEMMED

Basic Information

• Brand Name: FREEDOM STEMMED
• Primary DI: 00811767024488
• Version / Model: RSUU2135-RK
• Company Name: MAXX ORTHOPEDICS, INC.
• Labeler DUNS: 792030103
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-01
• Public Version: 4
• Public Version Date: 2020-04-20
• Public Version Status: Update
• Public Device Record Key: 05ce46ea-86fd-4e0c-9b58-7ff93b47f749

Device Description

Stem Extension 13.5x75mm

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	888.3560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48066	Knee femur stem prosthesis	A sterile device designed to provide additional stability for an implanted knee femur prosthesis by extending the attachment of the prosthesis from the distal femur into the midshaft of the bone. It is typically a shaft-like device made of metal [e.g., cobalt-chrome (Co-Cr)] and is often used in prosthesis revision to compensate for bone loss.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811767024488	GS1

Premarket Submissions

Submission Number	Supplement Number
K111785	000

Device Sizes

Type	Value	Unit	Text
Length	75	Millimeter
Width	13.5	Millimeter