Cleared Traditional

CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) (K253676) - FDA 510(k) Clearance

K253676 · Providence Medical Technology, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
174d
Days
-
Risk

K253676 is an FDA 510(k) clearance for the CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D). Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Providence Medical Technology, Inc. (Pleasanton, US). The FDA issued a Cleared decision on May 14, 2026 after a review of 174 days - an extended review 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: 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 Providence Medical Technology, Inc. devices

Submission Details

510(k) Number K253676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2025
Decision Date May 14, 2026
Days to Decision 174 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
52d slower than avg
Panel avg: 122d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Regulatory Consultant

R. Dubois Consulting, LLC
Roxanne Dubois

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 76
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K253676.
DiversiVy™ Facet Screw System
K253432 · Vy Spine, LLC · Mar 2026
Ion-C
K251714 · SurGenTec, LLC · Jan 2026
FFX Facet Fixation System
K250679 · Sc Medica · Dec 2025
CORUS-LX Implant
K253190 · Providence Medical Technology, Inc. · Nov 2025
FFX Facet Fixation System
K252153 · Sc Medica · Oct 2025
CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant
K251885 · Providence Medical Technology, Inc. · Jul 2025