LogoFDA 510(k) Search
K Number
K964094

Validate with FDA (Live)

Device Name
MINIFIX
Manufacturer
FERGUSON MEDICAL
Date Cleared
1996-11-27

(47 days)

Product Code
KTT
Regulation Number
888.3030
Type
Traditional
Panel
Orthopedic
Age Range
All
Reference & Predicate Devices
K861766,K880282
Predicate For
K023314,K051017,K093550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

external fixation of fractures and/or the reconstruction of small bones, including, but not limited to, metacarpal and metatarsal.

Device Description

The MINIFIX is a unilateral external fixator designed for use on small bones such as the metacarpal.

AI/ML Overview

I am sorry but this document is discussing a 510(k) summary for a medical device called "MINIFIX", which is an external fixator for small bones. The document describes its classification, substantial equivalence, device description, intended use, and technological characteristics. It does not contain any information about acceptance criteria, study details, sample sizes, ground truth, or expert involvement as requested in your prompt regarding the performance evaluation of a device. Therefore, I cannot extract the requested information from the provided text.

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Ferguson Medical. The logo has a stylized letter 'F' on the left side. To the right of the 'F' is the text 'FERGUSON MEDICAL' stacked on top of each other. The text and the 'F' are in a bold, sans-serif font.

916-342-4133 FAX: 916-343-454

NOV 27 1996

01 September 1996

K964094 510(k) SUMMARY

The 510(k) summary information required by 21 CFR 807.92 is as follows:

  • Component, traction, A. Classification name: invasive, or pin, fixation, threaded.
    Common/usual name: Unilateral mini-fixator, finger fixator, etc.

MINIFIX Proprietary name:

  • equivalence: Howmedica Hoffmann B. Substantial Fixation Pin System (K861766), Lima-LTO SEM External Stabilizer (K880282) and Modular others.
  • Device description: The MINIFIX is a unilateral C. . external fixator designed for use on small bones such as the metacarpal.
    • The MINIFIX is intended for use in D. Intended use: external fixation of fractures and/or the reconstruction of small bones, including, but not limited to, metacarpal and metatarsal.
    • The MINIFIX device E. Technological characteristics:

{1}------------------------------------------------

is similar to predicate devices in its design, function, and intended use.

The proposed device is quite simple in its configuration and design, therefore requires a minimum of instrumentation to install.

Submitted, FERGUSON MEDICAL Establishment Registration Number 2937794

Frank Feur

Frank Ferguson Official Correspondent

N/A