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Ozark Cervical Plate System

by K2M, Inc.

510(k) K172104

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK172104 Date23 Aug 2017ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Ozark(tm) Cervical Plate System
510(k) Number
FDA product code
KWQ
Device class
Class II
Regulation
21 CFR Part 888.3060
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ozark Cervical Plate System is a spinal fixation device designed for intervertebral body applications. It features a per-level, integrated locking cover that provides visual and tactile confirmation of the final lock position. The system includes a fixed all-in-one Drill Guide that accommodates a Drill, Tap, Awl, and screwdriver.

The Ozark Cervical Plate System is supplied in various plate sizes and screw dimensions for surgical use. It is a Class II device with special controls, cleared by the FDA on August 23, 2017 under 510(k) number K172104. The system is manufactured by K2m, Inc. and is intended for orthopedic applications.

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