Cleared Special

K150954 - Elite L Expandable Lumbar Fusion System

K150954 is an FDA 510(k) clearance for Elite L Expandable Lumbar Fusion System, manufactured by Innova Spinal Technologies, LLC. The device is a Class 2 Orthopedic device with product code MAX cleared through the Special 510(k) pathway after a 28-day FDA review.

K150954 · Innova Spinal Technologies, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
28d
Days
Class 2
Risk

K150954 is an FDA 510(k) clearance for the Elite L Expandable Lumbar Fusion 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 Innova Spinal Technologies, LLC (Boca Raton, US). The FDA issued a Cleared decision on May 7, 2015 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K150954

510(k) Number K150954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2015
Decision Date May 07, 2015
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

MAX Device Classification - Class 2, Special Controls

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 896
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K150954.
Lucent
K150061 · Spinal Elements, Inc. · May 2015
SpineFrontier Lumbar Interbody Fusion Device System
K142504 · Spinefrontier, Inc. · May 2015
The Octane Straight Intervertebral Fusion Device, Ti Coated
K150152 · Exactech, Inc. · May 2015
Zavation Posterior LEIF
K142392 · Zavation, LLC · Apr 2015
NuVasive(R) CCX-L Interbody System
K143595 · Nu Vasive, Incorporated · Apr 2015
INTERBODY CAGE
K140348 · Eisertech, LLC · Apr 2015