Spinal Concepts, Inc. Infix System

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

510(k) Number

K031672 ↗

FDA Product Code

MQP

Device Class

Class II

Regulation

21 CFR Part 888.3060

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Spinal Concepts, Inc. Insight Pedicle Screw System

  Class II

  FDA 510(k) K031855 Active Cleared 17 Sep 2003

• Universal Bone Plate III System (Ubp III)

  Class II

  FDA 510(k) K020611 Active Cleared 27 Mar 2002

• Modification to Incompass Spinal Fixation System

  Class II

  FDA 510(k) K023644 Active Cleared 25 Nov 2002

• Spinal Concepts, Inc., Universal Bone Plate System II

  Class II

  FDA 510(k) K973586 Active Cleared 7 Nov 1997

• Spinal Concepts Cadence and Traxis

  Class II

  FDA 510(k) K033517 Active Cleared 18 Feb 2004

• Harmony Port System, Model 1907 Series

  Class II

  FDA 510(k) K050706 Active Cleared 15 Apr 2005

See all devices from Spinal Concepts, Inc. →

• What is the Spinal Concepts Infix System used for?

  The Spinal Concepts Infix System is an orthopedic device designed for spinal fixation and stabilization during surgical procedures. It provides support and alignment to the spine as needed during these operations.

• Is the Infix System reusable or single-use?

  The Infix System is supplied as a sterile device and is intended for single-use only. It should not be reused on multiple patients as this could compromise sterility and device performance.

• What are the storage requirements for the Infix System?

  The Infix System should be stored according to the manufacturer's instructions. It is important to follow these storage guidelines to maintain the device's integrity and functionality until use.

• Is the Infix System MRI compatible?

  No, the Spinal Concepts Infix System is not MRI compatible. Patients with this device should not undergo MRI scans as it could interfere with the imaging process or potentially cause harm.