The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Trident Ii Acetabular System.
| Device ID | K063616 |
| 510k Number | K063616 |
| Device Name: | TRIDENT II ACETABULAR SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Manal Morcos |
| Correspondent | Manal Morcos HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-05 |
| Decision Date | 2006-12-20 |
| Summary: | summary |