Class Class II
NEST-C Interbody System (K220261)
Description
NEST-C Interbody System by Paonan Biotech Co., Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK220261
Clearance Date2023-04-24
Clearance TypeTraditional
Product CodeODP
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K220261
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. NEST-C Interbody System (K220261) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K180230 | NEST Interbody System | Paonan Biotech Co., Ltd. | 2019 |
| K142251 | AVS AS PEEK Spacer | Stryker Corporation | 2014 |
Trace the full predicate network for K220261
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.