Class Class II
Uni-FuZe-C Bone Strip (K221726)
Description
Uni-FuZe-C Bone Strip by Zavation Medical Products, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221726
Clearance Date2023-01-18
Clearance TypeTraditional
Product CodeMQV
Regulation Number888.3045
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221726
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. Uni-FuZe-C Bone Strip (K221726) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201781 | Uni-FuZe-P Bone Putty | Zavation Medical Products, LLC | 2020 |
| K082166 | MASTERGRAFT STRIP | Medtronic Sofamor Danek | 2009 |
| K051386 | MASTERGRAFT PUTTY BONE VOID FILLER | Medtronic Vascular | 2005 |
Trace the full predicate network for K221726
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.