Class Class II
FIX-L PEEK PLIF and T-PLIF System (K243973)
Description
FIX-L PEEK PLIF and T-PLIF System by Jeil Medical Corporation, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243973
Clearance Date2025-06-12
Clearance TypeTraditional
Product CodeMAX
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243973
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. FIX-L PEEK PLIF and T-PLIF System (K243973) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212266 | FIX-C PEEK Anterior Cervical Interbody System | Jeil Medical Corporation | 2021 |
| K190563 | 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS... | Solco Biomedical Co., Ltd. | 2019 |
Trace the full predicate network for K243973
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.