Cleared Traditional

K150223 - Facet-Link Stabilization Platform

K150223 · Facet-Link, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
88d
Days
-
Risk

K150223 is an FDA 510(k) clearance for the Facet-Link Stabilization Platform. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Facet-Link, Inc. (Rockaway, US). The FDA issued a Cleared decision on April 28, 2015 after a review of 88 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.

FDA 510(k) Submission Details - K150223

510(k) Number K150223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2015
Decision Date April 28, 2015
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

MRW Device Classification - Class 0,

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

Regulatory Consultant

Hogan Lovells US LLP
Janice M Hogan

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 78
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K150223.
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