PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System (K230808)
Description
PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System by Kyocera Medical Technologies, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230808
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. PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System (K230808) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K180502 | S128 Anterior Lumbar Interbody Fusion (ALIF) System | Renovis Surgical Technologies, Inc. | 2018 |
| K131122 | S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM | Renovis Surgical Technologies, LLC | 2013 |
Trace the full predicate network for K230808
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.