K233150 is an FDA 510(k) clearance for the NET BRAND Osteosynthesis Nailing System. This device is classified as a Nail, Fixation, Bone (Class II - Special Controls, product code JDS).
Submitted by Narang Medical , Ltd. (Delhi, IN). The FDA issued a Cleared decision on February 20, 2024, 146 days after receiving the submission on September 27, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K233150 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2023 |
| Decision Date | February 20, 2024 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDS - Nail, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |