Nano FortiCore, FortiCore
FDA 510(k) K191822 · Nanovis, LLC
510(k) numberK191822
Submission
- Device name
- Nano FortiCore, FortiCore
- Applicant
- Nanovis, LLC
Columbia City, IN, US - Received
- July 8, 2019
- Decision date
- October 11, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODP – Intervertebral Fusion Device With Bone Graft, Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Other 510(k)s with product code ODP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262595 | VariLift-C Cervical Interbody Fusion SystemODP · Special | Wenzel Spine, Inc. | 08/26/2026SE |
| K262489 | BluEX Cervical Expandable Cage SystemODP · Special | L&K BIOMED Co., Ltd. | 08/18/2026SE |
| K253041 | 3d Cage CervicalODP · Traditional | Fims Co., Ltd. | 07/23/2026SE |
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…ODP · Special | Stryker Spine | 07/17/2026SE |
| K254130 | C.A. Medical Interbody Fusion SystemODP · Special | C.A. Medical, LLC | 07/08/2026SE |
| K260840 | BluEX Cervical Expandable Cage SystemODP · Traditional | L&K BIOMED Co., Ltd. | 05/16/2026SE |
| K260850 | Osteomni Spinal Cages SystemODP · Traditional | Osteomni, Inc. | 05/12/2026SE |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemODP · Special | Zsfab, Inc. | 04/24/2026SE |
| K253260 | ORIO-3D Cage SystemODP · Traditional | SpineCraft | 04/16/2026SE |
| K260340 | HC Biologics Osteopoint PEEK Cages, HC Biologics Osteopoint Cervical PEEK Cages, HC…ODP · Traditional | HC Biologics, LLC | 04/13/2026SE |
More from HC Biologics, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K241605 | Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System…MAX · Traditional | 09/05/2024SE |
| K230936 | Anatomic PEEK Cervical Fusion System with NanotechnologyODP · Traditional | 06/02/2023SE |
| K203452 | Nano FortiFix® SystemNKB · Special | 12/22/2020SE |
| K171312 | FortiCore®MAX · Traditional | 01/22/2018SE |
| K161485 | Nanovis Intervertebral Body Fusion System and Forticore(R)MAX · Traditional | 09/06/2016SE |
| K160874 | Nanovis Intervertebral Body Fusion System and FortiCore®MAX · Special | 06/28/2016SE |
| K140280 | ForticoreODP · Traditional | 09/05/2014SE |
| K113173 | Nanovis Spinal SystemNKB · Traditional | 01/19/2012SE |
| K110442 | Nanovis Intervertebral Body Fusion SystemODP · Traditional | 11/09/2011SE |
Questions and answers
When was Nano FortiCore, FortiCore cleared by the FDA?
Nano FortiCore, FortiCore (K191822) received a 510(k) decision of Substantially Equivalent on October 11, 2019, 95 days after the submission was received.
What is the product code of K191822?
The FDA product code is ODP – Intervertebral Fusion Device With Bone Graft, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.