Class Class II
Fine Osteotomy™ (K231314)
Description
Fine Osteotomy™ by Bodycad Laboratories, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK231314
Clearance Date2023-06-02
Clearance TypeSpecial
Product CodePBF
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K231314
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. Fine Osteotomy™ (K231314) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211646 | FINE Osteotomy | Bodycad Laboratories, Inc. | 2021 |
| K183105 | Mimics Medical | Materialise NV | 2019 |
Trace the full predicate network for K231314
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.