Ortho Select Bone Plates And Screw System

by Ortho Select Implant Technology Gesellschaft

510(k) K091493

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

510(k) K091493↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK091493	Date5 Feb 2010Cleared	StatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K091493
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 Ortho Select Bone Plates and Screw System is a fixation device comprising bone plates and screws intended for the stabilization of fractures in adult and pediatric patients. It is indicated for pelvic, small, and long bone fracture fixation and may also be used for hip arthrodesis on mature bone.

The system is supplied non‑sterile for user steam sterilization and is designated for single‑use only. It received FDA 510(k) clearance (K091493) as a substantially equivalent, traditional clearance under product code HRS.