Cleared Traditional

K192281 - AEGIS Anterior Lumbar Plate System

K192281 · Medos International SARL · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
90d
Days
-
Risk

K192281 is an FDA 510(k) clearance for the AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior I.... Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Medos International SARL (Le Locle, CH). The FDA issued a Cleared decision on November 20, 2019 after a review of 90 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 Medos International SARL devices

Submission Details

510(k) Number K192281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2019
Decision Date November 20, 2019
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Regulatory Consultant

Depuy Synthes Spine
Sergio M. Cordeiro

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 48
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K192281.
FaSet Fixation System
K222515 · Dio Medical Corporation · Oct 2022
Ion Facet Screw System
K211855 · SurGenTec, LLC · Feb 2022
CORRIDOR Fixation System
K192744 · Globus Medical, Inc. · Dec 2019
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