Cleared Traditional

K200549 - Lucero Medical Cervical Cage System

K200549 is the FDA 510(k) clearance for Lucero Medical Cervical Cage System by Lucero Medical, LLC. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K200549 · Lucero Medical, LLC · Orthopedic device
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Dec 2020
Decision
288d
Days
Class 2
Risk

K200549 is an FDA 510(k) clearance for the Lucero Medical Cervical Cage System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Lucero Medical, LLC (Richfield, US). The FDA issued a Cleared decision on December 16, 2020 after a review of 288 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Lucero Medical, LLC devices

Submission Details

510(k) Number K200549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2020
Decision Date December 16, 2020
Days to Decision 288 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 122d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Backroads Consulting, Inc.
Karen E. Warden

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 208
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K200549.
ZSFab Cervical Interbody System
K202488 · Zsfab, Inc. · Jan 2021
Tailored-C Cervical Interbody Fusion System
K200458 · Bespoke Technologies · Dec 2020
ChoiceSpine Tiger Shark Cervical Spacer System
K201643 · Choice Spine, LLC · Dec 2020
Atlas Spine Rebar (Ti) Spacer System
K202302 · Atlas Spine, Inc. · Oct 2020
CONSTRUX Mini PEEK Spacer System
K202949 · Orthofix, Inc. · Oct 2020
CONSTRUX Mini PTC Spacer System
K202666 · Orthofix, Inc. · Oct 2020