Cleared Traditional

K071420 - CHAMELEON FIXATION SYSTEM

K071420 · Spinefrontier, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K071420

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 122d · This submission: 239d
Pathway characteristics
Predicate-based equivalence.

MRW Device Classification - Class 0,

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

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 78
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K071420.
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TRANS1 FACET SCREW
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DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02
K062391 · Triage Medical, Inc. · Sep 2006
US SPINE FACET FIXATION SYSTEM
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K052043 · Triage Medical, Inc. · Oct 2005
K071420 · CHAMELEON FIXATION SYSTEM
Download PDF FDA Summary Spinefrontier, Inc.