Cleared Traditional

K130202 - IRIS ANTERIOR CERVICAL PLATE

K130202 is the FDA 510(k) clearance for IRIS ANTERIOR CERVICAL PLATE by Life Spine, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K130202 · Life Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
91d
Days
Class 2
Risk

K130202 is an FDA 510(k) clearance for the IRIS ANTERIOR CERVICAL PLATE. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Life Spine, Inc. (Hoffman Estates, US). The FDA issued a Cleared decision on April 29, 2013 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Life Spine, Inc. devices

Submission Details

510(k) Number K130202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2013
Decision Date April 29, 2013
Days to Decision 91 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
31d faster than avg
Panel avg: 122d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 438
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K130202.
TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM
K132012 · Zimmer Spine, Inc. · Aug 2013
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K130640 · Medtronic Sofamor Danek USA, Inc. · Jun 2013
AZURE ANTERIOR CERVICAL PLATE SYSTEM
K130825 · Orthofix, Inc. · May 2013
NUVASIVE LONG LATERAL SPINAL SYSTEM
K122081 · Nuvasive, Inc. · Feb 2013
DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM
K123167 · Medos International SARL · Dec 2012
ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
K121514 · Corelink, LLC · Dec 2012