Class Class II
Pisces™-SA STANDALONE ALIF Interbody System (K223413)
Description
Pisces™-SA STANDALONE ALIF Interbody System by Osseus Fusion Systems, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223413
Clearance Date2023-02-10
Clearance TypeTraditional
Product CodeOVD
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223413
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. Pisces™-SA STANDALONE ALIF Interbody System (K223413) cites 1 predicate device and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243386 | Ventris Intervertebral Body Fusion Device | Acuity Surgical Devices, LLC | 2025 |
| K240126 | ProAM ALIF System | Pro Surgical, Inc. | 2024 |
Trace the full predicate network for K223413
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.