Cleared Traditional

K130863 - FACET SCREW SYSTEM

K130863 · Spinal USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
134d
Days
-
Risk

K130863 is an FDA 510(k) clearance for the FACET SCREW SYSTEM. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Spinal USA (Philedelphia, US). The FDA issued a Cleared decision on August 9, 2013 after a review of 134 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 Spinal USA devices

FDA 510(k) Submission Details - K130863

510(k) Number K130863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2013
Decision Date August 09, 2013
Days to Decision 134 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
12d slower than avg
Panel avg: 122d · This submission: 134d
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 55
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K130863.
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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