K230118 is an FDA 510(k) clearance for the Bony Trauma Extremity System (BTES) Screw Range, NX Nail. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Field Orthopaedics Pty, Ltd. (Teneriffe, AU). The FDA issued a Cleared decision on February 16, 2023, 30 days after receiving the submission on January 17, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K230118 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 2023 |
| Decision Date | February 16, 2023 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HWC - Screw, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |