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Lucero Medical Cervical Cage System

by Lucero Medical, LLC

510(k) K200549

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 NumberK200549 Date16 Dec 2020ClearedStatusActive

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  • Withdrawn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
ODP
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Lucero Medical Cervical Cage System is an additively manufactured interbody fusion device designed for use in the cervical spine. It is intended to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion.

This device is intended to be used with supplemental fixation cleared for use in the cervical spine. It has received FDA 510(k) clearance under K200549.

Other devices from Lucero Medical, LLC

Questions

AI-generated answers, 22 Sep 2026

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

  • What is the intended use of the Lucero Medical Cervical Cage System?

    This device is an additively manufactured interbody fusion cage designed specifically for the cervical spine. It is intended to facilitate fusion when used in conjunction with autogenous or allogeneic bone graft, specifically cancellous or corticocancellous bone.

  • Does the system require additional hardware for implantation?

    Yes, the Lucero Medical Cervical Cage System is intended to be used with supplemental fixation that has been cleared for use in the cervical spine to ensure proper stability during the fusion process.

  • What is the regulatory status of this cervical cage system?

    The Lucero Medical Cervical Cage System has received FDA 510(k) clearance under K200549. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.