Cleared Traditional

K073643 - TRANS1 AXIALIF 2-LEVEL OR II SYSTEM

K073643 is an FDA 510(k) clearance for TRANS1 AXIALIF 2-LEVEL OR II SYSTEM, manufactured by Trans1 Incorporated. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K073643 · Trans1 Incorporated · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
124d
Days
Class 2
Risk

K073643 is an FDA 510(k) clearance for the TRANS1 AXIALIF 2-LEVEL OR II SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Trans1 Incorporated (Wilmington, US). The FDA issued a Cleared decision on April 28, 2008 after a review of 124 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 Trans1 Incorporated devices

FDA 510(k) Submission Details - K073643

510(k) Number K073643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2007
Decision Date April 28, 2008
Days to Decision 124 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
2d slower than avg
Panel avg: 122d · This submission: 124d
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 500
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K073643.
ARCOFIX
K080020 · Synthes Spine Co.Lp · May 2008
C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM
K080646 · Biomet Spine · May 2008
MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM
K080429 · Medtronic Sofamor Danek USA, Inc. · Apr 2008
MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM
K080690 · Theken Spine, LLC · Apr 2008
TOSCA II ANTERIOR CERVICAL PLATE SYSTEM
K080815 · Signus Medizintechnik GmbH · Apr 2008
EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM
K080191 · Depuy Spine, Inc. · Apr 2008