Cleared Abbreviated

S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM (K131122) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K131122 · Renovis Surgical Technologies, LLC · Orthopedic device
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Sep 2013
Decision
149d
Days
Class 2
Risk

K131122 is an FDA 510(k) clearance for the S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Renovis Surgical Technologies, LLC (Ashland, US). The FDA issued a Cleared decision on September 18, 2013 after a review of 149 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Renovis Surgical Technologies, LLC devices

Submission Details

510(k) Number K131122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2013
Decision Date September 18, 2013
Days to Decision 149 days
Submission Type Abbreviated
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 122d · This submission: 149d
Pathway characteristics
Standards-based clearance path.

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 110
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