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Emerge Medical Distal Radius Set

by Emerge Medical

510(k) K140107

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 NumberK140107 Date13 Mar 2014ClearedStatusActive

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  • Withdrawn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
HRS
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Distal Radius Set is a metallic bone fixation system designed for internal bone alignment and fracture stabilization. It is indicated for the fixation of complex intra-articular and extra-articular fractures and osteotomies.

The system comprises stainless steel plates with 6 and 9 locking hole head variations and 3 and 5 hole shafts, along with bone screws and associated installation and removal instruments. This device is classified as a Class 2 medical device and received FDA 510(k) clearance under K140107.

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