Class Class II
NOVA Minimally Invasive System (K242899)
Description
NOVA Minimally Invasive System by Baui Biotech Co., Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242899
Clearance Date2024-10-17
Clearance TypeSpecial
Product CodeNKB
Regulation Number888.3070
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242899
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. NOVA Minimally Invasive System (K242899) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K182416 | NOVA Minimally Invasive System | Baui Biotech Co., Ltd. | 2019 |
Trace the full predicate network for K242899
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.