# Nanovis, LLC

- Location (FDA's records): Columbia City, IN
- FDA decisions: 10 (2011–2024): 10 510(k) clearances
- Product codes: ODP (4), MAX (4), NKB (2)
- 510(k) review time since 2016: median 93 days, against 114 for FDA's reviews in the same codes and years (4 of 7 faster)
- Predicates its devices cite: 53 (16 its own); citations of its devices by later devices: 20 (16 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Depuy Spine, Inc.: 6 (https://510kreport.com/company/depuy-spine)
- K2m, Inc.: 4 (https://510kreport.com/company/k2m)
- Medtronic Sofamor Danek USA, Inc.: 4 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Ldr Spine USA: 3 (https://510kreport.com/company/ldr-spine-usa)
- Spinal USA: 3 (https://510kreport.com/company/spinal-usa)
- Medtronic Sofamor Danek: 2 (https://510kreport.com/company/medtronic-sofamor-danek)
- Depuyacromed: 2 (https://510kreport.com/company/depuyacromed)
- Nanovis Spine, LLC: 1 (https://510kreport.com/company/nanovis-spine)

## Firms that cite its devices most
- Osseus Fusion Systems, LLC: 1 (https://510kreport.com/company/osseus-fusion-systems)
- Neuropro Spinaljaxx, Inc.: 1 (https://510kreport.com/company/neuropro-spinaljaxx)
- Nanovis Spine, LLC: 1 (https://510kreport.com/company/nanovis-spine)
- X-Spine Systems, Inc.: 1 (https://510kreport.com/company/x-spine-systems)

## Its most-cited devices
- K140280: Forticore (2014), cited by 6
- K110442: Nanovis Intervertebral Body Fusion System (2011), cited by 4
- K161485: Nanovis Intervertebral Body Fusion System and Forticore (R) (2016), cited by 3
- K160874: Nanovis Intervertebral Body Fusion System and FortiCore® (2016), cited by 2
- K113173: Nanovis Spinal System (2012), cited by 2
- K191822: Nano FortiCore, FortiCore (2019), cited by 2

## Recent decisions
- K241605: Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology (Sep 5, 2024)
- K230936: Anatomic PEEK™ Cervical Fusion System with Nanotechnology (Jun 2, 2023)
- K203452: Nano FortiFix® System (Dec 22, 2020)
- K191822: Nano FortiCore, FortiCore (Oct 11, 2019)
- K171312: FortiCore® (Jan 22, 2018)
- K161485: Nanovis Intervertebral Body Fusion System and Forticore (R) (Sep 6, 2016)
- K160874: Nanovis Intervertebral Body Fusion System and FortiCore® (Jun 28, 2016)
- K140280: Forticore (Sep 5, 2014)

Source page: https://510kreport.com/company/nanovis