Fixation System

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

510(k) Number

K983318 ↗

FDA Product Code

GDW

Device Class

Class II

Regulation

21 CFR Part 878.4750

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Spacemaker Surgical Balloon Dissector & Cannula

  Class II

  FDA 510(k) K952278 Active Cleared 7 Aug 1995

• The Spacemaker and the Spacemaker II

  Class II

  FDA 510(k) K944418 Active Cleared 1 Nov 1994

• Surgical Patch Spreader

  Class II

  FDA 510(k) K931425 Active Cleared 22 Feb 1994

• Spacemaker Surgicalballoon Dissector/Expander

  Class I

  FDA 510(k) K972109 Active Cleared 14 Nov 1997

• Spacemaker, II Surgical Balloon Dissector with and Without a Cannula

  Class II

  FDA 510(k) K951878 Active Cleared 29 Jun 1995

• Mammary Sizer

  Unclassified

  FDA 510(k) K961356 Active Cleared 23 Sep 1996

See all devices from General Surgical Innovations →

• What is the Fixation System used for?

  The Fixation System is an implantable staple device used in general and plastic surgery procedures for tissue approximation and wound closure in surgical applications, as stated in the device description.

• How is the Fixation System supplied and is it reusable?

  The Fixation System is supplied non-sterile and is intended for single-use only, meaning it should not be reused after a procedure to ensure patient safety and device integrity.

• What regulatory pathway was used for the Fixation System?

  The Fixation System is regulated as a Class II medical device under FDA 510(k) clearance K983318, with product code GDW and regulation number 878.4750, indicating it received traditional 510(k) clearance as substantially equivalent to a predicate device.