FAICO CMF System MMPP-0.75-8-YY-MB

Listed FDA GUDID listing, not in commercial distribution

Overview

The FAICO CMF System is a small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, cover a burr hole and/or position/stabilize a prosthesis.

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00840192713766 UDI-DI	Date26 Sep 2020Listed	StatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name: FAICO CMF System
Generic Name: Craniofacial fixation plate, non-bioabsorbable, non-customized
Model / Reference: MMPP-0.75-8-YY-MB

Primary DI / UDI-DI: 00840192713766
FDA Product Code: JEY
GMDN Term: Craniofacial fixation plate, non-bioabsorbable, non-customized

Device Class: Class II
Regulation Number: 872.4760
GUDID distribution status: Not in Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

Other devices from Faico Medical LLC

FAICO Dental Implant System and CAD/CAM Abutments

Class II
Faico Dental Implant System

Class II
FAICO CMF System

Class II

Properties

Single Use
Implantable
Prescription Use
Lot / Batch Number
Expiration Date
Manufacturing Date

Other properties (8)

Sterile: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No