Nanovis Spinal System
FDA 510(k) K113173 · Nanovis, LLC
510(k) numberK113173
Submission
- Device name
- Nanovis Spinal System
- Applicant
- Nanovis, LLC
Chesterland, OH, US - Received
- October 27, 2011
- Decision date
- January 19, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262828 | KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special | S.M.A.I.O | 09/04/2026SE |
| K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…NKB · Traditional | MANTIZ Co., Ltd. | 07/24/2026SE |
| K253943 | Tiger 2 SystemNKB · Traditional | Zavation Medical Products, LLC | 07/24/2026SE |
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemNKB · Traditional | Alphatec Spine, Inc. | 07/14/2026SE |
| K253802 | KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special | S.M.A.I.O | 07/01/2026SE |
| K253045 | Socko Vimax Spinal Fixation SystemNKB · Traditional | Socko Medical Co., Ltd. | 06/17/2026SE |
| K251251 | ChanPin Pedicle Screw Spinal SystemNKB · Traditional | Chanpin Medtak Co., Ltd. | 06/09/2026SE |
| K260989 | Varion Thoracolumbar Fixation SystemNKB · Traditional | Kyocera Medical Technologies Inc. (KMTI) | 05/15/2026SE |
| K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5…NKB · Traditional | Globus Medical, Inc. | 05/07/2026SE |
| K261130 | AccelFix Spinal Fixation SystemNKB · Special | L&K BIOMED Co., Ltd. | 05/05/2026SE |
More from L&K BIOMED Co., Ltd.
| 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 |
| K191822 | Nano FortiCore, FortiCoreODP · Traditional | 10/11/2019SE |
| 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 |
| K110442 | Nanovis Intervertebral Body Fusion SystemODP · Traditional | 11/09/2011SE |
Questions and answers
When was Nanovis Spinal System cleared by the FDA?
Nanovis Spinal System (K113173) received a 510(k) decision of Substantially Equivalent on January 19, 2012, 84 days after the submission was received.
What is the product code of K113173?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.