Triathlon® X3® UHMWPE Tibial Inserts And Patellar Components
Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Howmedica Osteonics Corp Aka Stryker Orthopaedics
The following data is part of a premarket notification filed by Howmedica Osteonics Corp Aka Stryker Orthopaedics with the FDA for Triathlon® X3® Uhmwpe Tibial Inserts And Patellar Components.
Pre-market Notification Details
| Device ID | K172634 |
| 510k Number | K172634 |
| Device Name: | Triathlon® X3® UHMWPE Tibial Inserts And Patellar Components |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | Howmedica Osteonics Corp Aka Stryker Orthopaedics 325 Corporate Dr. Mahwah, NJ 07430 |
| Contact | Shahrir Alam |
| Correspondent | Shahrir Alam Howmedica Osteonics Corp Aka Stryker Orthopaedics 325 Corporate Dr. 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 | 2017-09-01 |
| Decision Date | 2017-11-16 |
| Summary: | summary |
NIH GUDID Devices
Trademark Results [Triathlon]
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.