Surgical Dynamics Mesh Cage System

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

510(k) Number

K003709 ↗

FDA Product Code

MQP

Device Class

Class II

Regulation

21 CFR Part 888.3060

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Modified Auto Suture Endoscopic Gia Surg. Stapler*

  Class II

  FDA 510(k) K900129 Active Cleared 27 Feb 1990

• Auto Suture(R) Endoscopic Gia(Tm) Surgical Stapler

  Class II

  FDA 510(k) K892233 Active Cleared 28 Apr 1989

• Caprosyn Absorbable Suture

  Class II

  FDA 510(k) K032586 Active Cleared 17 Nov 2003

• Auto Suture Disposable Gia Surg. Stapler

  Class I

  FDA 510(k) K801590 Active Cleared 4 Aug 1980

• Endoscope Suture & Carrier

  Class II

  FDA 510(k) K912973 Active Cleared 27 Sep 1991

• Modified Surgiport Disposable Trocar and Sleeve

  Class I

  FDA 510(k) K903419 Active Cleared 9 Aug 1990

See all devices from United States Surgical, A Division of Tyco Healthc →

• What is the primary function of the Surgical Dynamics Mesh Cage System?

  This device is designed to serve as a spinal vertebral body replacement. Its primary purpose is to provide necessary structural support within the spinal column.

• How is this device classified for regulatory purposes?

  The system is classified under the orthopedic medical specialty and is subject to the regulations governing spinal vertebral body replacement devices. It received FDA 510(k) clearance under number K003709.

• Who is the manufacturer of the Surgical Dynamics Mesh Cage System?

  The device is manufactured by United States Surgical, a division of Tyco Healthcare, located in Norwalk, Connecticut.