The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Trident Porous Titanium Acetabular Component With Peri-apatite Coating.
| Device ID | K013475 |
| 510k Number | K013475 |
| Device Name: | TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Margaret F Crowe |
| Correspondent | Margaret F Crowe HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-19 |
| Decision Date | 2001-12-20 |
| Summary: | summary |