Class Class II
OsteoFlo HydroFiber (K243949)
Description
OsteoFlo HydroFiber by SurGenTec, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243949
Clearance Date2025-05-28
Clearance TypeTraditional
Product CodeMQV
Regulation Number888.3045
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243949
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. OsteoFlo HydroFiber (K243949) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242797 | OsteoFlo HydroFiber | SurGenTec, LLC | 2024 |
| K163621 | Vitoss Bioactive (BA) Injectable | Orthovita, Inc. | 2017 |
| K140375 | MASTERGRAFT PUTTY, MASTERGRAFT STRIP | Medtronic Sofamor Danek USA, Inc. | 2014 |
Trace the full predicate network for K243949
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.