The following data is part of a premarket notification filed by Howmedica Osteonics Corp. Dba Stryker Orthopaedics with the FDA for Triathlon Total Kneesystem.
Device ID | K201343 |
510k Number | K201343 |
Device Name: | Triathlon Total KneeSystem |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | Howmedica Osteonics Corp. Dba Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 |
Contact | Shikha Khandelwal |
Correspondent | Shikha Khandelwal Howmedica Osteonics Corp. Dba Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-05-20 |
Decision Date | 2020-07-10 |