The following data is part of a premarket notification filed by Tornier Inc. with the FDA for Latitude Ev™ Total Elbow Arthroplasty.
Device ID | K193247 |
510k Number | K193247 |
Device Name: | LATITUDE EV™ Total Elbow Arthroplasty |
Classification | Prosthesis, Elbow, Semi-constrained, Cemented |
Applicant | Tornier Inc. 10801 Nesbitt Ave South Bloomington, MN 55347 |
Contact | Renee Stoffel |
Correspondent | Renee Stoffel Tornier Inc. 10801 Nesbitt Ave South Bloomington, MN 55347 |
Product Code | JDB |
CFR Regulation Number | 888.3160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-11-25 |
Decision Date | 2020-08-05 |