The following data is part of a premarket notification filed by Stryker Orthopaedics with the FDA for Triathlon Total Knee System.
Device ID | K173849 |
510k Number | K173849 |
Device Name: | Triathlon Total Knee System |
Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
Applicant | Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 |
Contact | Margaret Crowe Klippel |
Correspondent | Margaret Crowe Klippel Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 |
Product Code | MBH |
CFR Regulation Number | 888.3565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-12-19 |
Decision Date | 2018-02-02 |
Summary: | summary |