Class Class II
Synthecure Synthetic Calcium Sulfate (K250141)
Description
Synthecure Synthetic Calcium Sulfate by Austin Medical Ventures, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250141
Clearance Date2025-05-16
Clearance TypeTraditional
Product CodeMQV
Regulation Number888.3045
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250141
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. Synthecure Synthetic Calcium Sulfate (K250141) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K141830 | STIMULAN KIT, STIMULAN RAPID CURE | Biocomposites, Ltd. | 2015 |
Trace the full predicate network for K250141
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.