Skip to content

Sbi Distal Radius Volar Plating System

by Small Bone Innovations, Inc.

510(k) K070793

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 NumberK070793 Date30 May 2007ClearedStatusActive

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  • Withdrawn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, 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 Sbi Distal Radius Volar Plating System is an orthopedic device designed to provide internal fixation for distal radial fractures. The system comprises metallic plates and screws, with plates available in various sizes and right or left hand configurations. The screws include both cortical and cancellous types, with some featuring locking capability at varying angles.

This device is intended for use by orthopedic surgeons. It has received FDA 510(k) clearance as a class 2 medical device under K070793.

Other devices from Small Bone Innovations, Inc.

See all devices from Small Bone Innovations, Inc. →