SixFix Circular Fixation System

Basic Information

• Brand Name: SixFix Circular Fixation System
• Primary DI: 00850030203243
• Version / Model: 1
• Catalog Number: 76-11200
• Company Name: Amdt Holdings, Inc.
• Labeler DUNS: 117990191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-15
• Public Version: 2
• Public Version Date: 2021-11-23
• Public Version Status: Update
• Public Device Record Key: 2d860eee-8258-436c-9ae7-7991f6c9b8de

Device Description

Threaded Rods, 200mm

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48011	External orthopaedic fixation system, single-use	An assembly of devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850030203243	GS1

Customer Contacts

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