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510(k) K082795

SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT by Interventional Spine, Inc. — Product Code MRW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2008
Date Received
September 23, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Facet Screw Spinal Device
Device Class
Class U
Regulation Number
Review Panel
OR
Submission Type

Other clearances by Interventional Spine, Inc.

  • K160464 — Opticage(R) Expandable Interbody Fusion Device (April 4, 2016)
  • K152156 — Opticage Expandable Interbody Fusion Device (October 19, 2015)
  • K140716 — OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE (November 24, 2014)
  • K133583 — OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070 (February 10, 2014)
  • K132479 — OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00 (September 19, 2013)
  • K113527 — OPTICAGE INTERBODY FUSION DEVICE (January 20, 2012)
  • K090767 — PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER (June 11, 2009)

Other clearances for product code MRW

  • K251714 — Ion-C (January 16, 2026)
  • K250679 — FFX Facet Fixation System (December 4, 2025)
  • K253190 — CORUS-LX Implant (November 20, 2025)
  • K252153 — FFX Facet Fixation System (October 16, 2025)
  • K251885 — CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant (July 10, 2025)
  • K250920 — Arthrex Spine Compression FT Screw (May 22, 2025)
  • K242527 — The Karma® Fixation System (May 21, 2025)
  • K243865 — AERO MIS Facet Fusion System (March 24, 2025)
  • K243265 — Ion 3D (December 4, 2024)
  • K242650 — zLOCK Lumbar Facet Fixation System (September 20, 2024)