Cleared Traditional

K163374 - ALLY Facet Screws

K163374 · Providence Medical Technology, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
77d
Days
-
Risk

K163374 is an FDA 510(k) clearance for the ALLY™ Facet Screws. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Providence Medical Technology, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on February 16, 2017 after a review of 77 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Providence Medical Technology, Inc. devices

FDA 510(k) Submission Details - K163374

510(k) Number K163374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2016
Decision Date February 16, 2017
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
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 56
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K163374.
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
FacetBRIDGE System
K152137 · Ldr Spine USA · Jan 2016
Proficient (TM) Facet Screw Spine System
K142980 · Spine Wave, Inc. · Jan 2015
INTEGRA FACET FIXATION SYSTEM
K132859 · Seaspine, Inc. · Nov 2013