The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Trident Hemispherical Acetabular Shells.
| Device ID | K013676 |
| 510k Number | K013676 |
| Device Name: | TRIDENT HEMISPHERICAL ACETABULAR SHELLS |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Jennifer A Daudelin |
| Correspondent | Jennifer A Daudelin HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-07 |
| Decision Date | 2001-12-05 |
| Summary: | summary |