The following data is part of a premarket notification filed by Tornier Inc. with the FDA for Latitude Ev Total Elbow Arthroplasty.
| Device ID | K182461 |
| 510k Number | K182461 |
| Device Name: | LATITUDE EV Total Elbow Arthroplasty |
| Classification | Prosthesis, Elbow, Semi-constrained, Cemented |
| Applicant | Tornier Inc. 10801 Nesbitt Ave South Bloomington, MN 55437 |
| Contact | Renee Stoffel |
| Correspondent | Renee Stoffel Tornier Inc. 10801 Nesbitt Ave South Bloomington, MN 55437 |
| Product Code | JDB |
| CFR Regulation Number | 888.3160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-10 |
| Decision Date | 2018-12-27 |
| Summary: | summary |