Cleared Traditional

K071990 - VALEO CERVICAL PLATE SYSTEM

K071990 is an FDA 510(k) clearance for VALEO CERVICAL PLATE SYSTEM, manufactured by Amedica Corp.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K071990 · Amedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
101d
Days
Class 2
Risk

K071990 is an FDA 510(k) clearance for the VALEO CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Amedica Corp. (Washington, US). The FDA issued a Cleared decision on October 29, 2007 after a review of 101 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 Amedica Corp. devices

FDA 510(k) Submission Details - K071990

510(k) Number K071990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2007
Decision Date October 29, 2007
Days to Decision 101 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
21d faster than avg
Panel avg: 122d · This submission: 101d
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 506
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K071990.
BODYFORM THORACIC FIXATION SYSTEM
K072407 · Theken Spine, LLC · Dec 2007
SYNTHES VECTRA-ONE SYSTEM
K071667 · Synthes Spine · Nov 2007
PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM
K071416 · Medtronic Sofamor Danek USA, Inc. · Nov 2007
NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM
K072339 · Nuvasive, Inc. · Oct 2007
SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM
K072546 · Depuy Spine, Inc. · Oct 2007
MODIFICATION TO SPINAL USA VBR SYSTEM
K070922 · Spinal USA · Sep 2007