Cleared Special

K003928 - TOWNLEY TRANSFACETPEDICULAR SCREW FIXAT...

K003928 · Medtronic Sofamor Danek, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
28d
Days
-
Risk

K003928 is an FDA 510(k) clearance for the TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on January 17, 2001 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic Sofamor Danek, Inc. devices

Submission Details

510(k) Number K003928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2000
Decision Date January 17, 2001
Days to Decision 28 days
Submission Type Special
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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 48
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K003928.
NUVASIVE TRIAD FACET SCREW SYSTEM
K020411 · Nuvasive, Inc. · Mar 2002
MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K013829 · Medtronic Sofamor Danek, Inc. · Dec 2001
DISCOVERY FACET SCREW FIXATION SYSTEM
K012773 · Depuyacromed · Nov 2001
NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW
K001323 · Nuvasive, Inc. · Jul 2000
NUVASIVE TOWNLEY FACET SCREW
K994308 · Nuvasive, Inc. · Apr 2000
TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM
K953076 · Sofamor Danek USA,Inc. · Feb 1997