Class Class II
ProAM ALIF System (K251644)
Description
ProAM ALIF System by Pro Surgical, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251644
Clearance Date2025-06-24
Clearance TypeSpecial
Product CodeOVD
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251644
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. ProAM ALIF System (K251644) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240126 | ProAM ALIF System | Pro Surgical, Inc. | 2024 |
| K222554 | EL CAPITAN Anterior Lumbar Interbody Fusion | Astura Medical | 2023 |
Trace the full predicate network for K251644
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.