Cleared Traditional

K112097 - GIBRALT SPINE SYSTEMS FACET SCREW 04.0

K112097 · Exactech, Inc. · Orthopedic device
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Nov 2011
Decision
122d
Days
-
Risk

K112097 is an FDA 510(k) clearance for the GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on November 21, 2011 after a review of 122 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 Exactech, Inc. devices

Submission Details

510(k) Number K112097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2011
Decision Date November 21, 2011
Days to Decision 122 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
At panel average
Panel avg: 122d · This submission: 122d
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 49
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K112097.
ZYGAFIX SPINAL FACET SCREW SYSTEM
K123932 · X-Spine Systems, Inc. · May 2013
ILLICO FS FACET FIXATION SYSTEM
K123218 · Alphatec Spine, Inc. · Nov 2012
RAPTOR FACET FIXATION SYSTEM
K110170 · Alphatec Spine, Inc. · Nov 2011
VIPER F2 FACET FIXATION SYSTEM
K101762 · Depuy Spine, Inc. · Nov 2010
PRIMALOK FACET FIXATION SYSTEM
K102438 · Osteomed LP · Sep 2010
FACET SCREW SYSTEM
K101284 · Nuvasive, Inc. · Jul 2010