Cleared Traditional

K994308 - NUVASIVE TOWNLEY FACET SCREW

K994308 · Nuvasive, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
119d
Days
-
Risk

K994308 is an FDA 510(k) clearance for the NUVASIVE TOWNLEY FACET 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 April 18, 2000 after a review of 119 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 - K994308

510(k) Number K994308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1999
Decision Date April 18, 2000
Days to Decision 119 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
3d faster than avg
Panel avg: 122d · This submission: 119d
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 K994308.
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
TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM
K953076 · Sofamor Danek USA,Inc. · Feb 1997