Cleared Traditional

K200084 - Zavation IBF System

K200084 is the FDA 510(k) clearance for Zavation IBF System by Zavation Medical Products, LLC. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 278-day FDA review.

K200084 · Zavation Medical Products, LLC · Orthopedic device
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Oct 2020
Decision
278d
Days
Class 2
Risk

K200084 is an FDA 510(k) clearance for the Zavation IBF System. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Zavation Medical Products, LLC (Flowood, US). The FDA issued a Cleared decision on October 19, 2020 after a review of 278 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 Zavation Medical Products, LLC devices

Submission Details

510(k) Number K200084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2020
Decision Date October 19, 2020
Days to Decision 278 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
156d slower than avg
Panel avg: 122d · This submission: 278d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize 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 Peers - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 595
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K200084.
FlareHawk Interbody Fusion System
K202198 · Integrity Implants, Inc. · Nov 2020
UNiD IB3D ALIF
K200316 · Medicrea International SA · Oct 2020
NuVasive Modulus XLIF Interbody System
K201692 · Nu Vasive, Incorporated · Oct 2020
Zavation IBF System
K202305 · Zavation Medical Products, LLC · Oct 2020
GAIA Lumbar Interbody Fusion Device (LIFD) Family
K201939 · Printerprezz · Oct 2020
Fortilink Cages with TiPlus Technology
K201453 · Paradigm Spine GmbH · Oct 2020