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Manual Surg. Instru. for Steinhauser Bone Plate

by Walter Lorenz Surgical, Inc. 510(k)

Active United States

510(k) K862533

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK862533 Date1 Aug 1986ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JEY
Device Class
Class II
Regulation
21 CFR Part 872.4760
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

This device is a Manual Surgical Instrument for Steinhauser Bone Plates, classified as a Class II medical device under FDA regulation 872.4760. It is designed to assist in the placement and manipulation of bone plates during orthopedic or dental surgical procedures, ensuring precise alignment and fixation of bone fragments or dental implants.

The instrument is intended for single-use in sterile surgical settings and is supplied as part of a dental specialty orthopedic toolkit. It is not MRI-compatible and must be handled with sterile technique. The device is authorized under FDA 510(k) clearance K862533, with a traditional review pathway, and is distributed by Walter Lorenz Surgical, Inc. under product code JEY.

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