Cleared Traditional

K133194 - DIAMOND RATTLESNAKE SYSTEM

K133194 is an FDA 510(k) clearance for DIAMOND RATTLESNAKE SYSTEM, manufactured by Eminent Spine. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K133194 · Eminent Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
252d
Days
Class 2
Risk

K133194 is an FDA 510(k) clearance for the DIAMOND RATTLESNAKE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Eminent Spine (Woodstock, US). The FDA issued a Cleared decision on June 26, 2014 after a review of 252 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 Eminent Spine devices

FDA 510(k) Submission Details - K133194

510(k) Number K133194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date June 26, 2014
Days to Decision 252 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
130d slower than avg
Panel avg: 122d · This submission: 252d
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 472
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K133194.
GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM
K133911 · Genesys Spine · Sep 2014
DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM
K140417 · Medtronic Sofamor Danek, Inc. · Jul 2014
SKYHAWK LATERAL PLATE SYSTEM
K140260 · Orthofix, Inc. · Jul 2014
META-C CERVICAL PLATE
K140361 · Medacta International · Jun 2014
TRINICA ANTERIOR LUMBAR PLATE SYSTEM
K140611 · Zimmer Spine, Inc. · May 2014
RELIANCE ANTERIOR CERVICAL PLATE
K140742 · Reliance Medical Systems, LLC · Apr 2014