Cleared Traditional

SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT (K082795) - FDA 510(k) Clearance

K082795 · Interventional Spine, Inc. · Orthopedic device
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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.

View all Interventional Spine, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 122d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MRW System, Facet Screw Spinal Device
Device Class -