The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Size 1 Triathlon Cruciate Retaining (cr) Tibial Insert.
| Device ID | K042883 |
| 510k Number | K042883 |
| Device Name: | SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Denise Duchene |
| Correspondent | Denise Duchene HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-19 |
| Decision Date | 2004-11-23 |
| Summary: | summary |