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Emerge Medical Cannulated Screw Fixation System

by Emerge Medical

510(k) K102343

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 NumberK102343 Date23 Nov 2010ClearedStatusActive

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  • Withdrawn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
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

The Emerge Medical Cannulated Screw Fixation System is a bone fixation device designed for the management of fractures in both small and large bones and bone fragments. It is indicated for use in the foot, patella, ankle, wrist, and elbow, as well as for arthrodesis and small and long bone osteotomies.

This device is identified by FDA 510(k) number K102343 and is classified under product code HWC. It has received FDA 510(k) clearance as a Class 2 medical device.

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