Cleared Traditional

K012773 - DISCOVERY FACET SCREW FIXATION SYSTEM

K012773 · Depuyacromed · Orthopedic device
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Optimized for regulatory review, auditing and printing
Nov 2001
Decision
88d
Days
-
Risk

K012773 is an FDA 510(k) clearance for the DISCOVERY FACET SCREW FIXATION SYSTEM. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Depuyacromed (Raynham, US). The FDA issued a Cleared decision on November 16, 2001 after a review of 88 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 Depuyacromed devices

FDA 510(k) Submission Details - K012773

510(k) Number K012773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2001
Decision Date November 16, 2001
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 50
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K012773.
MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM
K021705 · Medtronic Sofamor Danek, Inc. · Jul 2002
NUVASIVE TRIAD FACET SCREW SYSTEM
K020411 · Nuvasive, Inc. · Mar 2002
MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K013829 · Medtronic Sofamor Danek, Inc. · Dec 2001
TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K003928 · Medtronic Sofamor Danek, Inc. · Jan 2001
NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW
K001323 · Nuvasive, Inc. · Jul 2000
NUVASIVE TOWNLEY FACET SCREW
K994308 · Nuvasive, Inc. · Apr 2000