Cleared Traditional

K100154 - FIXCET SPINAL FACET SCREW SYSTEM

K100154 · X-Spine Systems, Inc. · Orthopedic device
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May 2010
Decision
121d
Days
-
Risk

K100154 is an FDA 510(k) clearance for the FIXCET SPINAL FACET SCREW SYSTEM. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by X-Spine Systems, Inc. (Miamisburg, US). The FDA issued a Cleared decision on May 21, 2010 after a review of 121 days - within the typical 510(k) review window.

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 X-Spine Systems, Inc. devices

Submission Details

510(k) Number K100154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2010
Decision Date May 21, 2010
Days to Decision 121 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
1d faster than avg
Panel avg: 122d · This submission: 121d
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 48
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K100154.
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
K112097 · Exactech, Inc. · Nov 2011
VIPER F2 FACET FIXATION SYSTEM
K101762 · Depuy Spine, Inc. · Nov 2010
FACET SCREW SYSTEM
K101284 · Nuvasive, Inc. · Jul 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