Cleared Traditional

K073515 - TRANS1 FACET SCREW

K073515 · Trans1 Incorporated · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
88d
Days
-
Risk

K073515 is an FDA 510(k) clearance for the TRANS1 FACET SCREW. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Trans1 Incorporated (Wilmington, US). The FDA issued a Cleared decision on March 11, 2008 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 Trans1 Incorporated devices

FDA 510(k) Submission Details - K073515

510(k) Number K073515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2007
Decision Date March 11, 2008
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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 59
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K073515.
ZYFUSE FACET FIXATION SYSTEM
K090952 · Globus Medical, Inc. · Jul 2009
LIFE SPINE FACET SCREW SPINAL SYSTEM
K090865 · Life Spine · Jun 2009
CORRIDOR FIXATION SYSTEM
K083442 · Globus Medical, Inc. · Feb 2009
CHAMELEON FIXATION SYSTEM
K071420 · Spinefrontier, Inc. · Jan 2008
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