K193247 is an FDA 510(k) clearance for the LATITUDE EV™ Total Elbow Arthroplasty. This device is classified as a Prosthesis, Elbow, Semi-constrained, Cemented (Class II - Special Controls, product code JDB).
Submitted by Tornier, Inc. (Bloomington, US). The FDA issued a Cleared decision on August 5, 2020, 254 days after receiving the submission on November 25, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3160.
| 510(k) Number | K193247 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 2019 |
| Decision Date | August 05, 2020 |
| Days to Decision | 254 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDB — Prosthesis, Elbow, Semi-constrained, Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3160 |