Cleared Special

K130630 - PLATEAU SPACER SYSTEM TITANIUM

K130630 is the FDA 510(k) clearance for PLATEAU SPACER SYSTEM TITANIUM by Life Spine, Inc.. It is a Class 2 Orthopedic device (product code MAX) cleared through the Special 510(k) pathway after a 97-day FDA review.

K130630 · Life Spine, Inc. · Orthopedic device
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Jun 2013
Decision
97d
Days
Class 2
Risk

K130630 is an FDA 510(k) clearance for the PLATEAU SPACER SYSTEM TITANIUM. 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 Life Spine, Inc. (Hoffman Estates, US). The FDA issued a Cleared decision on June 13, 2013 after a review of 97 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Life Spine, Inc. devices

Submission Details

510(k) Number K130630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2013
Decision Date June 13, 2013
Days to Decision 97 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
25d faster than avg
Panel avg: 122d · This submission: 97d
Pathway characteristics
Modification to existing cleared device.

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 609
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K130630.
CAPSTONE(R) SPINAL SYSTEM
K123027 · Medtronic Sofamor Danek, Inc. · Jul 2013
LIFE SPINE PLATEAU SPACER SYSTEM
K131077 · Life Spine · Jul 2013
MECTALIF
K131671 · Medacta International · Jul 2013
ALEUTIAN SPINAL SYSTEM
K130699 · K2m, Inc. · May 2013
RAMPART O
K131216 · Spineology, Inc. · May 2013
SYNTHES SYNCAGE EVOLUTION SPACER
K122639 · Synthes USA Products, LLC · May 2013