Anatomic PEEK™ Cervical Fusion System with Nanotechnology (K230936)
Description
Anatomic PEEK™ Cervical Fusion System with Nanotechnology by Nanovis, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230936
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Anatomic PEEK™ Cervical Fusion System with Nanotechnology (K230936) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192502 | Anatomic PEEK Cervical Fusion System, Anatomic PEEK PTC C... | Medtronic Sofamor Danek USA, Inc. | 2020 |
| K191822 | Nano FortiCore, FortiCore | Nanovis, LLC | 2019 |
| K160125 | Cascadia Interbody System | K2m | 2016 |
| K091088 | LDR SPINE CERVICAL INTERBODY FUSION SYSTEM | Ldr Spine USA | 2009 |
Trace the full predicate network for K230936
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.