Cleared Traditional

K073500 - ACTIVE ANTERIOR CERVICAL PLATE SYSTEM

K073500 is an FDA 510(k) clearance for ACTIVE ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Sanacor. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K073500 · Sanacor · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
203d
Days
Class 2
Risk

K073500 is an FDA 510(k) clearance for the ACTIVE ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Sanacor (American Fork, US). The FDA issued a Cleared decision on July 3, 2008 after a review of 203 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 Sanacor devices

FDA 510(k) Submission Details - K073500

510(k) Number K073500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2007
Decision Date July 03, 2008
Days to Decision 203 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
81d slower than avg
Panel avg: 122d · This submission: 203d
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 511
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K073500.
ANTEGRA-T
K081568 · Synthes Spine Co.Lp · Sep 2008
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K081038 · Medtronic Sofamor Danek · Aug 2008
SPINAL ELEMENTS BUTTRESS PLATE SYSTEM
K081418 · Spinal Elements, Inc. · Jul 2008
VIP ANTERIOR CERVICAL PLATE SYSTEM
K081391 · Globus Medical, Inc. · Jul 2008
THOR ANTERIOR PLATING SYSTEM
K080773 · Stryker Spine · Jun 2008
ARCOFIX
K080020 · Synthes Spine Co.Lp · May 2008