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Centaur Spinal System

by Howmedica Osteonics Corp.

510(k) K994347

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK994347 Date15 Mar 2000ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 19 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 Centaur Spinal System is a spinal fixation appliance designed for intervertebral body stabilization. Classified under product code KWQ, it falls under the category of spinal intervertebral body fixation devices, intended to provide structural support and alignment to the spine.

This system is supplied as a reusable medical device and is regulated under FDA 510(k) clearance (K994347) with a traditional review process. It was authorized for use in the United States following a review by the Orthopedic (OR) Advisory Committee, adhering to Class II special controls for spinal fixation devices.

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