Class Class II
SINEFIX (K220966)
Description
SINEFIX by BAAT Medical Products B.V., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK220966
Clearance Date2023-03-08
Clearance TypeTraditional
Product CodeMBI
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K220966
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. SINEFIX (K220966) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200028 | Coronet Soft Tissue Fixation System | Conextions Medical | 2020 |
| K162429 | ZipE Knotless Tissue Repair and Attachment Devices | Ziptek, LLC | 2017 |
| K062466 | ARTHREX INTERFERENCE SCREW | Arthrex, Inc. | 2006 |
| K051726 | ARTHREX TENODESIS FAMILY | Arthrex, Inc. | 2005 |
Trace the full predicate network for K220966
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.