Cleared Special

K013829 - MODIFICATION TO TOWNLEY TRANSFACETPEDIC...

K013829 · Medtronic Sofamor Danek, Inc. · Orthopedic device
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Dec 2001
Decision
30d
Days
-
Risk

K013829 is an FDA 510(k) clearance for the MODIFICATION TO 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 December 19, 2001 after a review of 30 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 K013829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2001
Decision Date December 19, 2001
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 K013829.
STRYKER SPINE OASYS BONE SCREW
K031657 · Howmedica Osteonics Corp. · Aug 2003
MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM
K021705 · Medtronic Sofamor Danek, Inc. · Jul 2002
NUVASIVE TRIAD FACET SCREW SYSTEM
K020411 · Nuvasive, Inc. · Mar 2002
DISCOVERY FACET SCREW FIXATION SYSTEM
K012773 · Depuyacromed · Nov 2001
TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K003928 · Medtronic Sofamor Danek, Inc. · Jan 2001
NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW
K001323 · Nuvasive, Inc. · Jul 2000