Cleared Traditional

K082795 - SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT

K082795 · Interventional Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
80d
Days
-
Risk

K082795 is an FDA 510(k) clearance for the SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Interventional Spine, Inc. (Irvine, US). The FDA issued a Cleared decision on December 12, 2008 after a review of 80 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 - K082795

510(k) Number K082795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2008
Decision Date December 12, 2008
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
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 K082795.
LIFE SPINE FACET SCREW SPINAL SYSTEM
K090865 · Life Spine · Jun 2009
PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER
K090767 · Interventional Spine, Inc. · Jun 2009
CORRIDOR FIXATION SYSTEM
K083442 · Globus Medical, Inc. · Feb 2009
TRANS1 FACET SCREW
K073515 · Trans1 Incorporated · Mar 2008
CHAMELEON FIXATION SYSTEM
K071420 · Spinefrontier, Inc. · Jan 2008
DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02
K062391 · Triage Medical, Inc. · Sep 2006