Cleared Traditional

K092568 - SPARTAN S3 FACET SYSTEM

K092568 · Amendia, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Nov 2009
Decision
89d
Days
-
Risk

K092568 is an FDA 510(k) clearance for the SPARTAN S3 FACET SYSTEM. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Amendia, Inc. (Apple Valley, US). The FDA issued a Cleared decision on November 17, 2009 after a review of 89 days - a notably fast clearance 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: 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 Amendia, Inc. devices

FDA 510(k) Submission Details - K092568

510(k) Number K092568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2009
Decision Date November 17, 2009
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
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 59
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K092568.
LANX FACET SCREW SYSTEM
K101364 · Lanx, Inc. · Aug 2010
FACET SCREW SYSTEM
K101284 · Nuvasive, Inc. · Jul 2010
FIXCET SPINAL FACET SCREW SYSTEM
K100154 · X-Spine Systems, Inc. · May 2010
SPINEOLOGY FACET SCREW
K092464 · Spineology, Inc. · Nov 2009
ZYFUSE FACET FIXATION SYSTEM
K090952 · Globus Medical, Inc. · Jul 2009
LIFE SPINE FACET SCREW SPINAL SYSTEM
K090865 · Life Spine · Jun 2009