Lorenz Pectus Support Bar
by Walter Lorenz Surgical, Inc. 510(k)
Active
510(k) K972420
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK972420 | Date11 Aug 1997 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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
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.
Other devices from Walter Lorenz Surgical, Inc.
Questions
AI-generated answers, 1 Oct 2026
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.