Cleared Special

K161798 - FacetBRIDGE® System

K161798 · Ldr Spine USA, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
35d
Days
-
Risk

K161798 is an FDA 510(k) clearance for the FacetBRIDGE® System. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Ldr Spine USA, Inc. (Austin, US). The FDA issued a Cleared decision on August 4, 2016 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K161798

510(k) Number K161798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2016
Decision Date August 04, 2016
Days to Decision 35 days
Submission Type Special
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
87d faster than avg
Panel avg: 122d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

MRW Device Classification - Class 0,

Product Code MRW System, Facet Screw Spinal Device
Device Class -

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 78
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K161798.
FaSet Fixation System
K180729 · Huvexel Co. , Ltd. · Jun 2018
Facet Screw Fixation System
K173198 · U&I Corporation · Jan 2018
ALLY™ Facet Screws
K163374 · Providence Medical Technology, Inc. · Feb 2017
FacetBRIDGE System
K152137 · Ldr Spine USA · Jan 2016
Facet-Link Stabilization Platform
K150223 · Facet-Link, Inc. · Apr 2015
Proficient (TM) Facet Screw Spine System
K142980 · Spine Wave, Inc. · Jan 2015