SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (K250472)
Description
SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) by Amdt Holdings, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250472
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. SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (K250472) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K190069 | SixFix Hexapod Fixator and Deformity Analysis and Correcti... | Arrowhead De, LLC | 2019 |
Trace the full predicate network for K250472
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.