Cleared Traditional

K001323 - NUVASIVE PERCUTANEOUS TRANSFACET/INTRAP...

K001323 · Nuvasive, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2000
Decision
90d
Days
-
Risk

K001323 is an FDA 510(k) clearance for the NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on July 25, 2000 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 Nuvasive, Inc. devices

FDA 510(k) Submission Details - K001323

510(k) Number K001323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2000
Decision Date July 25, 2000
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 55
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K001323.
MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K013829 · Medtronic Sofamor Danek, Inc. · Dec 2001
DISCOVERY FACET SCREW FIXATION SYSTEM
K012773 · Depuyacromed · Nov 2001
TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K003928 · Medtronic Sofamor Danek, Inc. · Jan 2001
NUVASIVE TOWNLEY FACET SCREW
K994308 · Nuvasive, Inc. · Apr 2000
TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM
K953076 · Sofamor Danek USA,Inc. · Feb 1997