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510(k) K160874

Nanovis Intervertebral Body Fusion System and FortiCore® by Nanovis, LLC — Product Code MAX

K160874 is an FDA 510(k) premarket notification submitted by Nanovis, LLC for the device "Nanovis Intervertebral Body Fusion System and FortiCore®". The FDA issued a decision of Substantially Equivalent on June 28, 2016. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), 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
June 28, 2016
Date Received
March 30, 2016
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 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)
  • K191822 — Nano FortiCore, FortiCore (October 11, 2019)
  • K171312 — FortiCore® (January 22, 2018)
  • K161485 — Nanovis Intervertebral Body Fusion System and Forticore(R) (September 6, 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 MAX

  • 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)
  • K260385 — aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and tran (May 9, 2026)
  • K261067 — BEE PLIF Cage (April 30, 2026)
  • K254017 — SWINGO-3D Lumbar Cage System (February 26, 2026)
  • K253583 — LUX Expandable Lumbar Interbody System (February 23, 2026)
  • K250773 — Luna® Ti Interbody Fusion System (February 4, 2026)

FDA data resources