Home / 510(k) Clearances / K111774

510(k) K111774

PATHWAY MODEL 07XXXX by Custom Spine — Product Code MAX

K111774 is an FDA 510(k) premarket notification submitted by Custom Spine for the device "PATHWAY MODEL 07XXXX". The FDA issued a decision of Substantially Equivalent on July 20, 2011. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Custom Spine has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2011
Date Received
June 23, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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

Other clearances by Custom Spine

  • K143143 — PATHWAY ELIF (July 22, 2015)
  • K132596 — PROPOSED OPTIMUS (April 11, 2014)
  • K120597 — KOMPREDA (May 3, 2013)
  • K111726 — PATHWAY AVID (February 6, 2012)
  • 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 MAX

  • K261049 — SCALA® TL (August 20, 2026)
  • K261430 — TruLift Expandable System (July 28, 2026)
  • K253011 — Catalyft PL Expandable Interbody System (July 17, 2026)
  • K261020 — Symmetrix™ L Spinal System (July 14, 2026)
  • K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Space (July 1, 2026)
  • K253151 — Fule Interbody Fusion Cage System (June 15, 2026)
  • K261159 — Exceed® Biplanar Expandable Interbody System (May 29, 2026)
  • K253894 — BMD Titanium Spinal Fusion System (May 28, 2026)
  • K260506 — Ventana® P/T Lumbar Interbody System (May 15, 2026)
  • K260837 — VersaLift Expandable System (May 12, 2026)

FDA data resources