Cleared Traditional

K042073 - OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM

K042073 is an FDA 510(k) clearance for OLSEN MEDICAL ANTERIOR CERVICAL VERTEBR..., manufactured by Olsen Medical. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K042073 · Olsen Medical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
189d
Days
Class 2
Risk

K042073 is an FDA 510(k) clearance for the OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Olsen Medical (Louisville, US). The FDA issued a Cleared decision on February 7, 2005 after a review of 189 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 Olsen Medical devices

FDA 510(k) Submission Details - K042073

510(k) Number K042073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2004
Decision Date February 07, 2005
Days to Decision 189 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
67d slower than avg
Panel avg: 122d · This submission: 189d
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 492
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K042073.
MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM
K050804 · Aesculap, Inc. · Apr 2005
SYNTHES VECTRA SYSTEM
K050451 · Synthes Spine Co.Lp · Mar 2005
MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM
K050117 · Medtronic Sofamor Danek · Feb 2005
PIONEER ANTERIOR CERVICAL PLATE SYSTEM
K043066 · Pioneer Surgical Technology · Feb 2005
GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS
K031782 · Medtronic Sofamor Danek · Feb 2005
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K043151 · Medtronic Sofamor Danek · Feb 2005