Cleared Traditional

K060025 - SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM

K060025 is an FDA 510(k) clearance for SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Spinal USA. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K060025 · Spinal USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
104d
Days
Class 2
Risk

K060025 is an FDA 510(k) clearance for the SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Spinal USA (Brandon, US). The FDA issued a Cleared decision on April 18, 2006 after a review of 104 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 Spinal USA devices

FDA 510(k) Submission Details - K060025

510(k) Number K060025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2006
Decision Date April 18, 2006
Days to Decision 104 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
18d faster than avg
Panel avg: 122d · This submission: 104d
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 470
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K060025.
UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM
K061229 · Blackstone Medical, Inc. · Jul 2006
OPTERYX ANTERIOR CERVICAL PLATE SYSTEM
K061147 · Innovasis, Inc. · Jun 2006
VENTURE ANTERIOR CERVICAL PLATE SYSTEM
K061274 · Medtronic Sofamor Danek · May 2006
EBI ANTERIOR CERVICAL PLATE SYSTEM
K060379 · Ebi, L.P. · Mar 2006
NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM
K053581 · Nuvasive, Inc. · Feb 2006
AEGIS ANTERIOR LUMBAR PLATE SYSTEM
K052546 · Depuy Spine, Inc. · Feb 2006