K192003 is an FDA 510(k) clearance for the Auxein Nailing System. This device is classified as a Nail, Fixation, Bone (Class II - Special Controls, product code JDS).
Submitted by Auxein Medical Private Limited (Sonipat, IN). The FDA issued a Cleared decision on June 10, 2020, 320 days after receiving the submission on July 26, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K192003 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2019 |
| Decision Date | June 10, 2020 |
| Days to Decision | 320 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 |