Cleared Traditional

K092464 - SPINEOLOGY FACET SCREW

K092464 · Spineology, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
90d
Days
-
Risk

K092464 is an FDA 510(k) clearance for the SPINEOLOGY FACET SCREW. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Spineology, Inc. (St. Paul, US). The FDA issued a Cleared decision on November 9, 2009 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 Spineology, Inc. devices

FDA 510(k) Submission Details - K092464

510(k) Number K092464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2009
Decision Date November 09, 2009
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.

MRW Device Classification - Class 0,

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

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 K092464.
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K090767 · Interventional Spine, Inc. · Jun 2009