Data / Medical devices / United States / Nanovis Spine, LLC
Nanovis Spine, LLC: FDA-registered device maker in Columbia City, IN, United States, 10 510(k) clearances
Nanovis Spine, LLC is registered with the FDA (registration 3009446038) in Columbia City, IN, United States. It lists 10 device types. The FDA files 10 510(k) clearances under its listings, the newest dated September 5, 2024. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3009446038
- Address
- 5865 E State Road 14, Columbia City, IN, United States, 46725
- Owner or operator
- Nanovis, LLC (10039378)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- January 3, 2012
- Registered through
- 2027
- Brand names listed
- Adaptix PEEK Interbody System with Nanotechnology, Anatomic PEEK Cervical Fusion System with Nanotechnology, FortiCore®, Nano FortiCore, Nano FortiFix, Nanovis Bone Awl, Nanovis Bone Funnel, Nanovis Bone Funnel Tamp and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Awl | HWJ | 1 | Specification developer | accessdata.fda.gov |
| Bender | HXW | 1 | Specification developer | accessdata.fda.gov |
| Extractor | HWB | 1 | Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Specification developer | accessdata.fda.gov |
| Tamp | HXG | 1 | Specification developer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 5, 2024 | K241605 | Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology | MAX | Substantially Equivalent | Nanovis, LLC | accessdata.fda.gov |
| June 2, 2023 | K230936 | Anatomic PEEK Cervical Fusion System with Nanotechnology | ODP | Substantially Equivalent | Nanovis, LLC | accessdata.fda.gov |
| December 22, 2020 | K203452 | Nano FortiFix® System | NKB | Substantially Equivalent | Nanovis, LLC | accessdata.fda.gov |
| October 11, 2019 | K191822 | Nano FortiCore, FortiCore | ODP | Substantially Equivalent | Nanovis, LLC | accessdata.fda.gov |
| January 22, 2018 | K171312 | FortiCore® | MAX | Substantially Equivalent | Nanovis, LLC | accessdata.fda.gov |
| October 26, 2016 | K162250 | FortiBridge Anterior Cervical Plate System | KWQ | Substantially Equivalent | Nanovis Spine, LLC | accessdata.fda.gov |
| September 6, 2016 | K161485 | Nanovis Intervertebral Body Fusion System and Forticore(R) | MAX | Substantially Equivalent | Nanovis, LLC | accessdata.fda.gov |
| April 10, 2015 | K143706 | FortiBridge Anterior Cervical Plate System | KWQ | Substantially Equivalent | Nanovis Spine, LLC | accessdata.fda.gov |
| September 5, 2014 | K140280 | FORTICORE | ODP | Substantially Equivalent | Nanovis, LLC | accessdata.fda.gov |
| November 9, 2011 | K110442 | NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM | ODP | Substantially Equivalent | Nanovis, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Appliance, Fixation, Spinal Intervertebral Body
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Screwdriver
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Bender
Updated September 5, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.