Cleared Traditional

K062391 - DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02

Also marketed or referenced as:
COMPRESSION TOOL, MODEL 6113-00
K062391 · Triage Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
29d
Days
-
Risk

K062391 is an FDA 510(k) clearance for the DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9.... Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Triage Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on September 14, 2006 after a review of 29 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.

FDA 510(k) Submission Details - K062391

510(k) Number K062391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2006
Decision Date September 14, 2006
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
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 78
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K062391.
SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT
K082795 · Interventional Spine, Inc. · Dec 2008
TRANS1 FACET SCREW
K073515 · Trans1 Incorporated · Mar 2008
CHAMELEON FIXATION SYSTEM
K071420 · Spinefrontier, Inc. · Jan 2008
US SPINE FACET FIXATION SYSTEM
K061041 · Us Spine · Jun 2006
3.8MM CS FACET COMPRESSION DEVICE
K052043 · Triage Medical, Inc. · Oct 2005
TRANS1 FACET SCREWS
K051856 · Trans1 Incorporated · Sep 2005
K062391 · DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02
Download PDF FDA Summary Triage Medical, Inc.