Cleared Traditional

Proficient (TM) Facet Screw Spine System (K142980) - FDA 510(k) Clearance

K142980 · Spine Wave, Inc. · Orthopedic device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 122d · This submission: 93d
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 30
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K142980.
PMT Facet Screw
K183589 · Providence Medical Technology, Inc. · Oct 2019
FaSet Fixation System
K180729 · Huvexel Co. , Ltd. · Jun 2018
Facet Screw Fixation System
K173198 · U&I Corporation · Jan 2018
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
K112097 · Exactech, Inc. · Nov 2011
STRYKER SPINE OASYS BONE SCREW
K031657 · Howmedica Osteonics Corp. · Aug 2003