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510(k) K191822

Nano FortiCore, FortiCore by Nanovis, LLC — Product Code ODP

K191822 is an FDA 510(k) premarket notification submitted by Nanovis, LLC for the device "Nano FortiCore, FortiCore". The FDA issued a decision of Substantially Equivalent on October 11, 2019. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Nanovis, LLC has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2019
Date Received
July 8, 2019
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 Nanovis, LLC

  • K241605 — Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spina (September 5, 2024)
  • K230936 — Anatomic PEEK™ Cervical Fusion System with Nanotechnology (June 2, 2023)
  • K203452 — Nano FortiFix® System (December 22, 2020)
  • K171312 — FortiCore® (January 22, 2018)
  • K161485 — Nanovis Intervertebral Body Fusion System and Forticore(R) (September 6, 2016)
  • K160874 — Nanovis Intervertebral Body Fusion System and FortiCore® (June 28, 2016)
  • K140280 — FORTICORE (September 5, 2014)
  • K113173 — NANOVIS SPINAL SYSTEM (January 19, 2012)
  • K110442 — NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM (November 9, 2011)

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