Cleared Traditional

K101284 - FACET SCREW SYSTEM

K101284 · Nuvasive, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2010
Decision
69d
Days
-
Risk

K101284 is an FDA 510(k) clearance for the FACET SCREW SYSTEM. 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 15, 2010 after a review of 69 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nuvasive, Inc. devices

Submission Details

510(k) Number K101284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2010
Decision Date July 15, 2010
Days to Decision 69 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
53d faster than avg
Panel avg: 122d · This submission: 69d
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 49
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K101284.
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
K112097 · Exactech, Inc. · Nov 2011
VIPER F2 FACET FIXATION SYSTEM
K101762 · Depuy Spine, Inc. · Nov 2010
PRIMALOK FACET FIXATION SYSTEM
K102438 · Osteomed LP · Sep 2010
FIXCET SPINAL FACET SCREW SYSTEM
K100154 · X-Spine Systems, Inc. · May 2010
SPINEOLOGY FACET SCREW
K092464 · Spineology, Inc. · Nov 2009
ZYFUSE FACET FIXATION SYSTEM
K090952 · Globus Medical, Inc. · Jul 2009