Cleared Traditional

BEE HA Cage (K203444) - FDA 510(k) Clearance

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

K203444 · NGMedical GmbH · Orthopedic device
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Mar 2021
Decision
115d
Days
Class 2
Risk

K203444 is an FDA 510(k) clearance for the BEE HA Cage. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by NGMedical GmbH (Nonnweiler, DE). The FDA issued a Cleared decision on March 18, 2021 after a review of 115 days - within the typical 510(k) review window.

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 NGMedical GmbH devices

Submission Details

510(k) Number K203444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2020
Decision Date March 18, 2021
Days to Decision 115 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
7d faster than avg
Panel avg: 122d · This submission: 115d
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

MRC Global, LLC
Christine Scifert

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 182
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K203444.
GPS Cervical Spacers
K210890 · G Surgical, LLC · Apr 2021
Blustone Synergy Interbody Fusion System
K203520 · Blustone Synergy, LLC · Apr 2021
CONSTRUX Mini Ti Spacer System
K203342 · Orthofix, Inc. · Mar 2021
Prase PEEK Anterior Cervical Interbody Spacer
K202872 · Gbs Commonwealth Co., Ltd. · Feb 2021
BEE Cages
K200429 · NGMedical GmbH · Jan 2021
Ti3Z Cervical Interbody System
K202398 · Zavation Medical Products, LLC · Jan 2021