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Salute Fixation System

by Davol Inc., Sub. C. R. Bard, Inc. 510(k)

Active United States

510(k) K050610

Overview

The Salute Fixation System is an implantable device used in laparoscopic/endoscopic or open surgical procedures for fixation of prosthetic material and approximation of tissue. It is classified as a staple and implantable device with a device class of 2.

The system is supplied in various sizes and configurations, including an 18cm reusable shaft with handle. It is authorized under FDA 510K clearance with product code GDW and regulation number 878.4750. The device is intended for use in general and plastic surgery procedures.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK050610 Date25 May 2005ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

8 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-1267-2007 FDA Unclassified (pre-2012) initiated 16 Jul 2007
    • Terminated Z-1269-2007 FDA Unclassified (pre-2012) initiated 16 Jul 2007
    • Terminated Z-1270-2007 FDA Unclassified (pre-2012) initiated 16 Jul 2007
    • Terminated Z-1268-2007 FDA Unclassified (pre-2012) initiated 16 Jul 2007
    • Terminated Z-1272-2007 FDA Unclassified (pre-2012) initiated 16 Jul 2007 via K050610, on the same 510(k)
    • Terminated Z-1266-2007 FDA Unclassified (pre-2012) initiated 16 Jul 2007

    Malformed constructs (straight shots) may form causing injury to user/patient

  • 2 recalls, same reason

    • Terminated Z-0375-2007 FDA Unclassified (pre-2012) initiated 27 Dec 2006
    • Terminated Z-0374-2007 FDA Unclassified (pre-2012) initiated 27 Dec 2006

    Inadequate directions for use in the Salute System. Labeling -Revised to provide updated instructions for use and proper servicing

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
GDW
Device Class
Class II
Regulation
21 CFR Part 878.4750
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Salute Fixation System used for?

    The Salute Fixation System is an implantable device used in laparoscopic/endoscopic or open surgical procedures for fixation of prosthetic material and approximation of tissue in general and plastic surgery procedures.

  • How is the Salute Fixation System supplied?

    The system is supplied in various sizes and configurations, including an 18cm reusable shaft with handle, allowing for flexibility in different surgical applications and preferences.

  • What is the regulatory status of the Salute Fixation System?

    The Salute Fixation System is authorized under FDA 510K clearance with product code GDW and regulation number 878.4750, classified as a class 2 staple and implantable device.

  • Is the Salute Fixation System reusable or single-use?

    The Salute Fixation System includes an 18cm reusable shaft with handle, indicating that certain components of the system are designed for multiple uses while maintaining sterility and functionality.