Cleared Traditional

K113170 - CERVICAL PLATE

K113170 is the FDA 510(k) clearance for CERVICAL PLATE by Eisertech, LLC. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K113170 · Eisertech, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
162d
Days
Class 2
Risk

K113170 is an FDA 510(k) clearance for the CERVICAL PLATE. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Eisertech, LLC (San Diego, US). The FDA issued a Cleared decision on April 6, 2012 after a review of 162 days - an extended review cycle.

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 Eisertech, LLC devices

Submission Details

510(k) Number K113170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2011
Decision Date April 06, 2012
Days to Decision 162 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 122d · This submission: 162d
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 374
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K113170.
NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM
K121837 · Nuvasive, Inc. · Jul 2012
UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K121049 · Globus Medical, Inc. · Jun 2012
PLYMOUTH THORACOLUMBAR PLATE SYSTEM
K120092 · Globus Medical, Inc. · Apr 2012
LEXUS ANTERIOR CERVICAL PLATE SYSTEM
K113509 · L & K Biomed Co., Ltd. · Jan 2012
K2M, PYRENEES CERVICAL PLATE SYSTEM
K113329 · K2m, Inc. · Jan 2012
DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM
K112724 · Medos International SARL · Nov 2011