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SBI Hand Fixation System

by Small Bone Innovations, LLC

510(k) K050462

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 NumberK050462 Date26 Apr 2005ClearedStatusActive

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  • Withdrawn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)

Full name
Sbi Hand Fixation System (Tm)
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, 24 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 Hand Fixation System is a plate and screw system for internal bone fixation. It consists of stainless steel plates and self-tapping cortex screws used in hand, wrist, and small bone procedures.

Plates are available in various configurations including straight, T, Y, Z, and compression styles. Screws are provided in diameters ranging from 1.5mm to 2.6mm. The system is supplied non-sterile and is intended for reusable use after appropriate cleaning and sterilization. It is regulated under FDA 510(k) clearance K050462 with product code HRS and classification name Plate, Fixation, Bone.

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Questions

AI-generated answers, 24 Sep 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 SBI Hand Fixation System used for?

    The SBI Hand Fixation System is used for internal bone fixation in hand, wrist, and small bone procedures, providing stabilization through stainless steel plates and self-tapping cortex screws.

  • Is the SBI Hand Fixation System supplied sterile or non-sterile?

    The SBI Hand Fixation System is supplied non-sterile and must be cleaned and sterilized by the user before each use, as it is designed for reusable application.

  • What sizes and configurations are available for the SBI Hand Fixation System?

    The system includes plates in straight, T, Y, Z, and compression styles, with self-tapping cortex screws available in diameters ranging from 1.5mm to 2.6mm to accommodate various anatomical needs in small bone fixation.