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510(k) K243673

Xenco Medical CancelleX Cervical Interbody System by Xenco Medical, LLC — Product Code ODP

K243673 is an FDA 510(k) premarket notification submitted by Xenco Medical, LLC for the device "Xenco Medical CancelleX Cervical Interbody System". The FDA issued a decision of Substantially Equivalent on January 29, 2025. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Xenco Medical, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2025
Date Received
November 27, 2024
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 Xenco Medical, LLC

  • K223059 — Xenco Medical InterAlign Cervical Interbody System (June 7, 2023)
  • K213456 — Xenco Medical Multilevel CerviKit (December 21, 2021)
  • K191074 — Sorrento Bone Graft Substitute (September 27, 2019)
  • K190364 — CancelleX Porous Titanium Lumbar Interbody Device (April 18, 2019)
  • K173933 — Sorrento Bioglass Bone Graft Substitute (September 13, 2018)
  • K180373 — CancelleX Porous Titanium Lumbar Interbody Device (August 24, 2018)
  • K170611 — SETx Pedicle Screw System (May 25, 2017)
  • K160313 — Xenco Medical Cervical Interbody System (October 21, 2016)
  • K161478 — Xenco Medical Posterior Cervical System (September 6, 2016)
  • K160986 — Xenco Medical Pedicle Screw System (May 4, 2016)

Other clearances for product code ODP

  • 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)
  • K242303 — MOD-C (April 1, 2026)
  • K252240 — Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (March 30, 2026)
  • K252432 — Flex-Z™ Cervical Cage (March 25, 2026)
  • K254105 — Hive™ Standalone Cervical System and Hive™ C Interbody System (February 13, 2026)
  • K252205 — Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Inte (January 16, 2026)

FDA data resources