Cleared Traditional

BALTEUM - ONE™ Lumbar Plate System (K213820) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213820 · Huvexel Co. , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2022
Decision
107d
Days
Class 2
Risk

K213820 is an FDA 510(k) clearance for the BALTEUM - ONE™ Lumbar Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Huvexel Co. , Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on March 25, 2022 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Huvexel Co. , Ltd. devices

Submission Details

510(k) Number K213820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2021
Decision Date March 25, 2022
Days to Decision 107 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
15d faster than avg
Panel avg: 122d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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

Dio Medical Corporation
Milan George

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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 244
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K213820.
Venus Cervical Plate System
K211718 · Artfx Medical, LLC · Jun 2022
Cervical Spine Truss System Plating Solution (CSTS-PS)
K212527 · 4Web Medical, Inc. · May 2022
Aggeris™-C
K220182 · Clariance · Mar 2022
EMERGE Anterior Cervical Plate System
K220275 · Evolution Spine · Mar 2022
AccuFit Lateral 2-Hole Plate
K220324 · Precision Spine, Inc. · Mar 2022
IMPEACE and IMPEACE-Uni Anterior Cervical Plate System
K220379 · Medynus, Inc. · Mar 2022