Cleared Traditional

K090952 - ZYFUSE FACET FIXATION SYSTEM (FDA 510(k) Clearance)

K090952 · Globus Medical, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2009
Decision
102d
Days
-
Risk

K090952 is an FDA 510(k) clearance for the ZYFUSE FACET FIXATION SYSTEM. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on July 14, 2009 after a review of 102 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 Globus Medical, Inc. devices

Submission Details

510(k) Number K090952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2009
Decision Date July 14, 2009
Days to Decision 102 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 122d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 75
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