Cleared Traditional

K080646 - C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM

K080646 is an FDA 510(k) clearance for C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Biomet Spine. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K080646 · Biomet Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
57d
Days
Class 2
Risk

K080646 is an FDA 510(k) clearance for the C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Biomet Spine (Parsippany, US). The FDA issued a Cleared decision on May 2, 2008 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biomet Spine devices

FDA 510(k) Submission Details - K080646

510(k) Number K080646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2008
Decision Date May 02, 2008
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
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 485
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K080646.
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
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