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Wright-Loc Spinal Fixation System

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K950074

Overview

The Wright-Loc Spinal Fixation System is a spinal fixation system designed to provide secure, rigid fixation with an inherent positive corrective force in the implant/sleeve assembly. It is used for spinal fixation. The system includes instrumentation for surgical techniques, such as those for King-Moe Type I, II, or III scoliosis.

The Wright-Loc Spinal Fixation System is supplied by Wright Medical Technology, Inc. and has received FDA 510K authorization. The device is classified under product code MNH and has been reviewed by the Orthopedic advisory committee. It is designed to provide rigid fixation and corrective force, with the hook body automatically moving forward during final seating.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK950074 Date11 Aug 1995ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
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United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Wright-Loc(Tm) Spinal Fixation System
510(k) Number
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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Questions

  • What is the Wright-Loc Spinal Fixation System used for?

    The Wright-Loc Spinal Fixation System is used for spinal fixation, including surgical techniques for King-Moe Type I, II, or III scoliosis, to provide secure and rigid fixation with corrective force.

  • How is the Wright-Loc Spinal Fixation System supplied?

    The Wright-Loc Spinal Fixation System is supplied by Wright Medical Technology, Inc.

  • What type of authorization has the Wright-Loc Spinal Fixation System received?

    The Wright-Loc Spinal Fixation System has received FDA 510K authorization, indicating it is substantially equivalent to a predicate device.

  • What product code is the Wright-Loc Spinal Fixation System classified under?

    The Wright-Loc Spinal Fixation System is classified under product code MNH, which is reviewed by the Orthopedic advisory committee.