Aurora Titanium Spinal Rod System

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

510(k) Number

K974213 ↗

FDA Product Code

MNH

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SN

• 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

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• What types of spinal procedures is the Aurora Titanium Spinal Rod System designed to support, and how does its titanium construction benefit the patient?

  The Aurora Titanium Spinal Rod System is specifically designed to provide internal stabilization during spinal fusion procedures, offering mechanical support to the spine. Its titanium construction ensures biocompatibility, reducing the risk of adverse reactions, and provides durability to maintain structural integrity over time. This makes it suitable for long-term spinal stabilization in clinical settings.

• Is the Aurora Titanium Spinal Rod System intended for single-use or can it be reused? How does this affect its clinical application?

  The Aurora Titanium Spinal Rod System is supplied as a reusable medical device. This allows for multiple uses in different patients, provided proper sterilization and maintenance protocols are followed, which can enhance cost-effectiveness in clinical settings while maintaining safety and performance.

• What regulatory pathway was followed for the FDA clearance of the Aurora Titanium Spinal Rod System, and what does this mean for its clinical use?

  The Aurora Titanium Spinal Rod System received FDA clearance through a 510(k) submission (K974213) under the Traditional 510(k) Review pathway, with a decision described as *Substantially Equivalent for Some Indications*. This means the device was determined to be comparable to a legally marketed predicate device for certain spinal stabilization applications, ensuring it meets FDA safety and effectiveness standards for orthopedic use.

• What components are included in the Aurora Titanium Spinal Rod System, and how do they work together to stabilize the spine?

  The system includes titanium rods, screws, hooks, crosslinks, and connectors. These components interlock to create a rigid framework that supports spinal segments, allowing surgeons to align and fuse vertebrae. The rods provide longitudinal stability, while screws and hooks anchor the system to specific vertebrae, ensuring proper positioning during fusion procedures.