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510(k) K120597

KOMPREDA by Custom Spine, Inc. — Product Code MRW

K120597 is an FDA 510(k) premarket notification submitted by Custom Spine, Inc. for the device "KOMPREDA". The FDA issued a decision of Substantially Equivalent on May 3, 2013. The device falls under product code MRW (System, Facet Screw Spinal Device), a Class U device. Custom Spine, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2013
Date Received
February 28, 2012
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 Custom Spine, Inc.

  • K143143 — PATHWAY ELIF (July 22, 2015)
  • K132596 — PROPOSED OPTIMUS (April 11, 2014)
  • K111726 — PATHWAY AVID (February 6, 2012)
  • K111774 — PATHWAY MODEL 07XXXX (July 20, 2011)
  • K111099 — ISSYS LP SPINAL FIXATION SYSTEM (May 5, 2011)
  • K101151 — REGENT ANTERIOR CERVICAL PLATE (May 19, 2010)
  • K092904 — PATHWAY IVB/VBR (December 22, 2009)
  • K091134 — CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE (August 17, 2009)
  • K090566 — PATHWAY AVID (June 1, 2009)
  • K080281 — PATHWAY (May 1, 2008)

Other clearances for product code MRW

  • K261209 — Ion-L (June 11, 2026)
  • K253676 — CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) (May 14, 2026)
  • K253432 — DiversiVy™ Facet Screw System (March 19, 2026)
  • 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)

FDA data resources