Medicon Epiplating System

Basic Information

• Brand Name: Medicon Epiplating System
• Primary DI: 04046826123697
• Version / Model: 68.80.41
• Catalog Number: 68.80.41
• Company Name: Medicon eG. Chirurgiemechaniker-Genossenschaft
• Labeler DUNS: 315492330
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2025-04-30
• Public Version: 1
• Public Version Date: 2025-05-08
• Public Version Status: New
• Public Device Record Key: 9fe0355e-2704-4cc3-af32-8aee9b4ff78c

Device Description

covering screw for prosthesis plates

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 Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
FZE	Prosthesis, Nose, Internal	General, Plastic Surgery	878.3680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47748	Orthopaedic fixation plate bending insert, reusable	A device that is inserted into the threaded or non-threaded hole of a metal orthopaedic fixation plate (e.g., trauma or craniofacial plate) prior to the surgeon bending the plate to conform to the anatomical shape of the implant site (e.g., jawbone or pelvis) in order to preserve the integrity of the holes which would otherwise deform, negating the entry of the bone screws that hold the plate in place. It is typically made of metal or synthetic material in the form of a short screw or pin-like device with a slotted head (for the acceptance of a screwdriver) used solely during the bending of plates that typically have a continuous row of screw holes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	04046826319946	GS1
Primary	04046826123697	GS1

Premarket Submissions

Submission Number	Supplement Number
K241253	000