Cleared Special

K140303 - ALAMO T

K140303 is an FDA 510(k) clearance for ALAMO T, manufactured by Alliance Partners, LLC. The device is a Class 2 Orthopedic device with product code MAX cleared through the Special 510(k) pathway after a 74-day FDA review.

K140303 · Alliance Partners, LLC · Orthopedic device
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Apr 2014
Decision
74d
Days
Class 2
Risk

K140303 is an FDA 510(k) clearance for the ALAMO T. 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 Alliance Partners, LLC (Memphis, US). The FDA issued a Cleared decision on April 21, 2014 after a review of 74 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.

View all Alliance Partners, LLC devices

FDA 510(k) Submission Details - K140303

510(k) Number K140303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2014
Decision Date April 21, 2014
Days to Decision 74 days
Submission Type Special
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
48d faster than avg
Panel avg: 122d · This submission: 74d
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 797
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K140303.
INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM
K133418 · Seaspine, Inc. · May 2014
XCAGE INTERBODY FUSION SYSTEM
K133514 · Ouroboros Medical · May 2014
OCTANE ELEVATE SPINAL IMPLANT SYSTEM
K123607 · Exactech, Inc. · Apr 2014
ANYPLUS
K131612 · GS Medical Co., Ltd. · Apr 2014
JULIET OL
K140474 · Spineart · Apr 2014
COGENT MED-LIF
K132738 · Cogent Spine, LLC · Apr 2014