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FEP Fixation System and Stylo Wrist Fixation System

by Meridan Medical

510(k) K032427

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK032427 Date9 Oct 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JEC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The FEP Fixation System and Stylo Wrist Fixation System is a modular external fixation device composed of components such as joints, bars, clamps, or screws. These components can be assembled to form a device indicated for the reconstruction and correction of bone segments in the human body.

The system is supplied as a non-sterile, reusable orthopedic device intended for use in clinical settings. It is classified as a Class II medical device under FDA regulation 888.3040, with product code JEC, and received 510(k) clearance (K032427) on October 9, 2003, following a traditional review process. The device is not MRI conditional, and no sterility or single-use claims are made in the provided data.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the FEP Fixation System and Stylo Wrist Fixation System used for?

    The system is indicated for the reconstruction and correction of bone segments in the human body. It is a modular external fixation device assembled from components such as joints, bars, clamps, or screws to stabilize bone during healing or correction procedures.

  • How is the FEP Fixation System and Stylo Wrist Fixation System supplied and is it sterile or single-use?

    The device is supplied as a non-sterile, reusable orthopedic device intended for use in clinical settings. No sterility or single-use claims are made in the provided data, meaning it must be cleaned and sterilized by the user before each use and can be reused after proper reprocessing.

  • What regulatory pathway and classification apply to the FEP Fixation System and Stylo Wrist Fixation System?

    The device is classified as a Class II medical device under FDA regulation 888.3040 with product code JEC. It received 510(k) clearance (K032427) on October 9, 2003, following a traditional review process and was found substantially equivalent to a predicate device.