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Lorenz Pectus Support Bar

by Walter Lorenz Surgical, Inc. 510(k)

Active United States

510(k) K972420

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK972420 Date11 Aug 1997ClearedStatusActive

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  • Withdrawn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 22 Oct 2026.

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, 1 Oct 2026

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

The Lorenz Pectus Support Bar is a device used in the surgical repair of Pectus Excavatum and chest wall deformities. It consists of pre-bent stainless steel or titanium bars and titanium stabilizers, featuring notches and holes for suturing to the lateral chest wall.

The bars are pre-shaped based on patient-specific CT scans and are available in lengths ranging from 7 to 17 inches with a width of 0.50 inches. The device is supplied as a sterile, single-use implant and is regulated under FDA 510(k) clearance K972420.

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Questions

AI-generated answers, 1 Oct 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 Lorenz Pectus Support Bar used for?

    The Lorenz Pectus Support Bar is used in the surgical repair of Pectus Excavatum and chest wall deformities, providing structural support after being pre-shaped from patient-specific CT scans to fit the individual anatomy.

  • How is the Lorenz Pectus Support Bar supplied and is it reusable?

    The device is supplied as a sterile, single-use implant, meaning it is intended for one-time use only and must not be reprocessed or reused to ensure patient safety and maintain sterility.

  • What materials and sizes are available for the Lorenz Pectus Support Bar?

    The Lorenz Pectus Support Bar consists of pre-bent stainless steel or titanium bars with titanium stabilizers, featuring notches and holes for suturing, and is available in lengths ranging from 7 to 17 inches with a consistent width of 0.50 inches.