Surgical Dynamics Rodding System

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

Full name

Surgical Dynamics Rodding System (Previously Known As the Aurora Titanium Spinal Rod System)

510(k) Number

K983197 ↗

FDA Product Code

KWP

Device Class

Class II

Regulation

21 CFR Part 888.3050

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 Surgical Dynamics Rodding System used for?

  The Surgical Dynamics Rodding System is a spinal fixation system comprising rods, screws, hooks, and crosslinks, used for immobilization and stabilization of spinal segments. It can function as an anterolateral/anterior system, nonpedicle posterior system, or pedicle screw system depending on configuration.

• At which spinal levels can this system be used?

  The system is indicated for spinal fixation when used as an anterolateral/anterior system consisting of rods and screws at the lumbar, thoracic, and cervical spine levels.

• What components are included in the Surgical Dynamics Rodding System?

  The system comprises rods, screws, hooks, and crosslinks, which can be configured to function as an anterolateral/anterior system, nonpedicle posterior system, or pedicle screw system depending on the specific clinical requirements.

• What is the regulatory status of this device?

  The Surgical Dynamics Rodding System has FDA 510(k) clearance with product code KWP, as submitted by United States Surgical, A Division of Tyco Healthc. It was determined to be substantially equivalent to predicate devices.