Cleared Traditional

K253676 - CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)

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

FDA 510(k) Submission Details - K253676

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.

MRW Device Classification - Class 0,

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 68
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K253676.
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Ion-C
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K252153 · Sc Medica · Oct 2025