Cleared Traditional

K113170 - CERVICAL PLATE

K113170 is an FDA 510(k) clearance for CERVICAL PLATE, manufactured by Eisertech, LLC. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K113170

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
Combination Product No
PCCP Authorized No
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.

KWQ Device Classification - Class 2, Special Controls

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 550
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K113170.
TEMPUS CERVICAL PLATE SYSTEM
K120515 · Neurostructures, LLC · May 2012
PIONEER LATERAL PLATE SYSTEM
K120724 · Pioneer Surgical Technology, Inc. · May 2012
PLYMOUTH THORACOLUMBAR PLATE SYSTEM
K120092 · Globus Medical, Inc. · Apr 2012
SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM
K112861 · Sintea Plustek, LLC · Feb 2012
CARDIFF ANTERIOR CERVICAL PLATE SYSTEM
K112206 · Seaspine, Inc. · Jan 2012
LEXUS ANTERIOR CERVICAL PLATE SYSTEM
K113509 · L & K Biomed Co., Ltd. · Jan 2012