Cleared Traditional

K071420 - CHAMELEON FIXATION SYSTEM

K071420 · Spinefrontier, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
239d
Days
-
Risk

K071420 is an FDA 510(k) clearance for the CHAMELEON FIXATION SYSTEM. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Spinefrontier, Inc. (Beverly, US). The FDA issued a Cleared decision on January 16, 2008 after a review of 239 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel. 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 Spinefrontier, Inc. devices

Submission Details

510(k) Number K071420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2007
Decision Date January 16, 2008
Days to Decision 239 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
117d slower than avg
Panel avg: 122d · This submission: 239d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MRW System, Facet Screw Spinal Device
Device Class -

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 45
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K071420.
SPINEOLOGY FACET SCREW
K092464 · Spineology, Inc. · Nov 2009
ZYFUSE FACET FIXATION SYSTEM
K090952 · Globus Medical, Inc. · Jul 2009
CORRIDOR FIXATION SYSTEM
K083442 · Globus Medical, Inc. · Feb 2009
STRYKER SPINE OASYS BONE SCREW
K031657 · Howmedica Osteonics Corp. · Aug 2003
MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM
K021705 · Medtronic Sofamor Danek, Inc. · Jul 2002
NUVASIVE TRIAD FACET SCREW SYSTEM
K020411 · Nuvasive, Inc. · Mar 2002