Class Class II
BioSphere Putty; BioSphere MIS Putty (K241167)
Description
BioSphere Putty; BioSphere MIS Putty by Synergy Biomedical, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241167
Clearance Date2024-12-20
Clearance TypeTraditional
Product CodeMQV
Regulation Number888.3045
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241167
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. BioSphere Putty; BioSphere MIS Putty (K241167) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222276 | CONDUIT Cages; FIBERGRAFT BG Putty | Depuy Spine | 2022 |
| K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent ... | Nu Vasive, Incorporated | 2021 |
| K173301 | BioSphere MIS Putty (BioSphere MIS) | Synergy Biomedical, LLC | 2018 |
Trace the full predicate network for K241167
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.