Cleared Traditional

K142980 - Proficient (TM) Facet Screw Spine System

K142980 · Spine Wave, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
93d
Days
-
Risk

K142980 is an FDA 510(k) clearance for the Proficient (TM) Facet Screw Spine System. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Spine Wave, Inc. (Shelton, US). The FDA issued a Cleared decision on January 16, 2015 after a review of 93 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 Spine Wave, Inc. devices

FDA 510(k) Submission Details - K142980

510(k) Number K142980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2014
Decision Date January 16, 2015
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
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 73
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K142980.
FacetBRIDGE® System
K161798 · Ldr Spine USA, Inc. · Aug 2016
FacetBRIDGE System
K152137 · Ldr Spine USA · Jan 2016
Facet-Link Stabilization Platform
K150223 · Facet-Link, Inc. · Apr 2015
INTEGRA FACET FIXATION SYSTEM
K132859 · Seaspine, Inc. · Nov 2013
SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM
K132126 · Spectrum Spine, LLC · Oct 2013
FACET SCREW SYSTEM
K130863 · Spinal USA · Aug 2013