Cleared Traditional

K090865 - LIFE SPINE FACET SCREW SPINAL SYSTEM (FDA 510(k) Clearance)

K090865 · Life Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
88d
Days
-
Risk

K090865 is an FDA 510(k) clearance for the LIFE SPINE FACET SCREW SPINAL SYSTEM. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Life Spine (Hoffman Estates, US). The FDA issued a Cleared decision on June 26, 2009 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 Life Spine devices

Submission Details

510(k) Number K090865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2009
Decision Date June 26, 2009
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.

Device Classification

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

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 75
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K090865.
DiversiVy™ Facet Screw System
K253432 · Vy Spine, LLC · Mar 2026
Ion-C
K251714 · SurGenTec, LLC · Jan 2026
FFX Facet Fixation System
K250679 · Sc Medica · Dec 2025
CORUS-LX Implant
K253190 · Providence Medical Technology, Inc. · Nov 2025
FFX Facet Fixation System
K252153 · Sc Medica · Oct 2025
CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant
K251885 · Providence Medical Technology, Inc. · Jul 2025