The following data is part of a premarket notification filed by Tornier Inc. with the FDA for Latitude Ev Total Elbow Arthroplasty.
Device ID | K171010 |
510k Number | K171010 |
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 | 2017-04-04 |
Decision Date | 2017-08-31 |