Class Class II
PRADO™ Lumbar Interbody Fusion System (K252113)
Description
PRADO™ Lumbar Interbody Fusion System by Bethesda Medical Devices, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK252113
Clearance Date2025-08-05
Clearance TypeSpecial
Product CodeMAX
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K252113
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. PRADO™ Lumbar Interbody Fusion System (K252113) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Inter... | Alphatec Spine | 2025 |
| K170395 | Talos® Lumbar (HA) PEEK IBF Devices | Meditech Spine, LLC | 2017 |
| K141443 | INFRONT LUMBAR INTERBODY FUSION SYSTEM | Infront Medical, LLC | 2014 |
Trace the full predicate network for K252113
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.