Bacfix Spinal Fixation System

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

510(k) Number

K013887 ↗

FDA Product Code

MNH

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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

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See all devices from Spinal Concepts, Inc. →

• What is the Bacfix Spinal Fixation System used for?

  The Bacfix Spinal Fixation System is used to provide temporary stability of the thoracic, thoracolumbar, or lumbar spine, and for patients with Grade 3 or Grade 4 spondylolisthesis at L5-S1.

• What materials are used to make the Bacfix Spinal Fixation System?

  The system is made of an alloy, such as stainless steel, and consists of various hooks and a posteriorly placed compression or distraction device.

• Is the Bacfix Spinal Fixation System supplied with all necessary components?

  Yes, the system is supplied with various components, including rods, hooks, locking wedges, screws, and transverse connectors, and is intended to be implanted.

• What is the regulatory status of the Bacfix Spinal Fixation System?

  The system has received FDA 510K authorization, indicating that it is substantially equivalent to a predicate device.