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Stabiliz Fixation System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K120651

by Stabiliz Orthopaedics

Identifiers

510(k) Number
K120651 FDA 510(k)
FDA Product Code
HRS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3030 FDA 510(k)
Regulation Number
888.3030 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Stabiliz Fixation System is a bone fixation plate and orthopedic hardware device classified under the HRS product code. It is intended for the fixation of fractures, osteotomies, and nonunions of the humerus, radius, ulna, distal tibia, and fibula.

The device is supplied as part of a fixation system that includes SPL locking screws. It received FDA 510(k) clearance (K120651) as substantially equivalent to a predicate device and is regulated as a Class II medical device under special controls. The system is manufactured by Stabiliz Orthopaedics, LLC and is intended for use in orthopedic surgical procedures.

Frequently asked questions

What is the Stabiliz Fixation System used for?

The Stabiliz Fixation System is intended for the fixation of fractures, osteotomies, and nonunions of the humerus, radius, ulna, distal tibia, and fibula, as it is a bone fixation plate and orthopedic hardware device designed for these specific skeletal sites.

What components are included with the Stabiliz Fixation System?

The device is supplied as part of a fixation system that includes SPL locking screws, which are provided alongside the bone fixation plate to enable secure orthopedic fixation during surgical procedures.

How was the Stabiliz Fixation System cleared for market?

The Stabiliz Fixation System received FDA 510(k) clearance (K120651) as substantially equivalent to a predicate device, meaning it was determined to be as safe and effective as a legally marketed device through a traditional review pathway.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: StabilizOrtho, STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW by STABILIZ ORTHOPAEDICS ..., K130731 FDA 510 (k) - STABILIZ FIXATION SYSTEM - SPL LOCKING ..., PDF 510(k) Summary - Food and Drug Administration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Stabiliz Orthopaedics
FDA Applicant
Stabiliz Orthopaedics, LLC

Sources (1)

  • FDA 510(k) K120651 24 fields · synced Sep 28, 2026