The following data is part of a premarket notification filed by Stryker Orthopaedics with the FDA for Triathlon Tritanium Cone Augments.
Device ID | K143393 |
510k Number | K143393 |
Device Name: | Triathlon Tritanium Cone Augments |
Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
Applicant | STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
Contact | Margaret Klippel |
Correspondent | Margaret 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 | 2014-11-26 |
Decision Date | 2015-01-13 |
Summary: | summary |