The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Latitude Elbow Prosthesis.
| Device ID | K100562 |
| 510k Number | K100562 |
| Device Name: | LATITUDE ELBOW PROSTHESIS |
| Classification | Prosthesis, Elbow, Semi-constrained, Cemented |
| Applicant | TORNIER, INC. 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
| Contact | Brahim Hadri |
| Correspondent | Brahim Hadri TORNIER, INC. 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
| Product Code | JDB |
| CFR Regulation Number | 888.3160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-01 |
| Decision Date | 2010-06-29 |
| Summary: | summary |