The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Triathlon Posterior Stabilized Femoral Component - Beaded With Peri-apatite, Triathlon Cruciate Retaining Femoral Component - Beaded With Peri-apatite.
Device ID | K200782 |
510k Number | K200782 |
Device Name: | Triathlon Posterior Stabilized Femoral Component - Beaded With Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - Beaded With Peri-Apatite |
Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
Applicant | Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 |
Contact | Nora O'connor |
Correspondent | Nora O'connor Howmedica Osteonics Corp. 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 | 2020-03-26 |
Decision Date | 2020-05-13 |