K190543 is an FDA 510(k) clearance for the Cannulated Hemi Implant. This device is classified as a Prosthesis, Toe, Hemi-, Phalangeal (Class II - Special Controls, product code KWD).
Submitted by Vilex IN Tennessee, Inc. (Mcminnville, US). The FDA issued a Cleared decision on May 31, 2019, 88 days after receiving the submission on March 4, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3730.
| 510(k) Number | K190543 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2019 |
| Decision Date | May 31, 2019 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWD - Prosthesis, Toe, Hemi-, Phalangeal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3730 |