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510(k) K092904

PATHWAY IVB/VBR by Custom Spine, Inc. — Product Code ODP

K092904 is an FDA 510(k) premarket notification submitted by Custom Spine, Inc. for the device "PATHWAY IVB/VBR". The FDA issued a decision of Substantially Equivalent on December 22, 2009. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Custom Spine, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2009
Date Received
September 21, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Custom Spine, Inc.

  • K143143 — PATHWAY ELIF (July 22, 2015)
  • K132596 — PROPOSED OPTIMUS (April 11, 2014)
  • K120597 — KOMPREDA (May 3, 2013)
  • 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)
  • 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 ODP

  • K262595 — VariLift-C Cervical Interbody Fusion System (August 26, 2026)
  • K262489 — BluEX Cervical Expandable Cage System (August 18, 2026)
  • K253041 — 3d Cage Cervical (July 23, 2026)
  • K262061 — Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Po (July 17, 2026)
  • K254130 — C.A. Medical Interbody Fusion System (July 8, 2026)
  • K260840 — BluEX Cervical Expandable Cage System (May 16, 2026)
  • K260850 — OSTEOMNI SPINAL CAGES SYSTEM (May 12, 2026)
  • K260549 — ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System (April 24, 2026)
  • K253260 — ORIO-3D Cage System (April 16, 2026)
  • K260340 — HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, (April 13, 2026)

FDA data resources