Nano FortiCore, FortiCore— 510(k) K191822
Substantially EquivalentNanovis, LLC
FDA 510(k) clearance K191822 for Nano FortiCore, FortiCore, Substantially Equivalent on 2019-10-11. Applicant: Nanovis, LLC. Device class: 2.
Clearance details
- Applicant
- Nanovis, LLC
- Product code
- Code ODP
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Columbia City, IN, US
Recent devices under product code ODP
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view all- K241605 — Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology
- K230936 — Anatomic PEEK Cervical Fusion System with Nanotechnology
- K203452 — Nano FortiFix® System
- K171312 — FortiCore®
- K161485 — Nanovis Intervertebral Body Fusion System and Forticore(R)
Adverse events under product code ODP
product code ODP- Injury
- 310
- Total
- 310
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.