Cleared Traditional

K230731 - Zavation ALIF System

K230731 is the FDA 510(k) clearance for Zavation ALIF System by Zavation Medical Products, LLC. It is a Class 2 Orthopedic device (product code OVD) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K230731 · Zavation Medical Products, LLC · Orthopedic device
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Jun 2023
Decision
90d
Days
Class 2
Risk

K230731 is an FDA 510(k) clearance for the Zavation ALIF System. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Zavation Medical Products, LLC (Flowood, US). The FDA issued a Cleared decision on June 14, 2023 after a review of 90 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 Zavation Medical Products, LLC devices

Submission Details

510(k) Number K230731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2023
Decision Date June 14, 2023
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 144
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K230731.
Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System
K232530 · Nexus Spine, LLC · Sep 2023
MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation
K232154 · MiRus, LLC · Sep 2023
NuVasive Modulus ALIF System
K230894 · Nu Vasive, Incorporated · Jun 2023
PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System
K230808 · Kyocera Medical Technologies, Inc. · Apr 2023
ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)
K221324 · Camber Spine Technologies · Mar 2023
Pisces™-SA STANDALONE ALIF Interbody System
K223413 · Osseus Fusion Systems · Feb 2023