Bony Trauma Extremity System (BTES) Screw Range, NX Nail (K230118)
Description
Bony Trauma Extremity System (BTES) Screw Range, NX Nail by Field Orthopaedics Pty, Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
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Predicate lineage for K230118
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. Bony Trauma Extremity System (BTES) Screw Range, NX Nail (K230118) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200043 | Field Orthopaedics Bony Trauma Extremity System (BTES) Plat... | Field Orthopaedics Pty, Ltd. | 2020 |
Trace the full predicate network for K230118
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.