Cleared Traditional

ZSFab Cervical Interbody System (K202488) - FDA 510(k) Clearance

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

K202488 · Zsfab, Inc. · Orthopedic device
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Jan 2021
Decision
129d
Days
Class 2
Risk

K202488 is an FDA 510(k) clearance for the ZSFab Cervical Interbody System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Zsfab, Inc. (Cambridge, US). The FDA issued a Cleared decision on January 7, 2021 after a review of 129 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 Zsfab, Inc. devices

Submission Details

510(k) Number K202488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2020
Decision Date January 07, 2021
Days to Decision 129 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 slower than avg
Panel avg: 122d · This submission: 129d
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 182
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K202488.
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
Tailored-C Cervical Interbody Fusion System
K200458 · Bespoke Technologies · Dec 2020
ChoiceSpine Tiger Shark Cervical Spacer System
K201643 · Choice Spine, LLC · Dec 2020
Lucero Medical Cervical Cage System
K200549 · Lucero Medical, LLC · Dec 2020