The following data is part of a premarket notification filed by Howmedica Osteonics with the FDA for Triathlon Cs (condylar Stabilizing) Lipped Insert.
| Device ID | K063423 |
| 510k Number | K063423 |
| Device Name: | TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | HOWMEDICA OSTEONICS 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Sheryl R Bagalio |
| Correspondent | Sheryl R Bagalio HOWMEDICA OSTEONICS 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 | 2006-11-13 |
| Decision Date | 2007-01-22 |
| Summary: | summary |