The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for 36mm Orthinox V40 Femoral Head Components.
| Device ID | K031730 |
| 510k Number | K031730 |
| Device Name: | 36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Debra Bing |
| Correspondent | Debra Bing HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-04 |
| Decision Date | 2003-08-29 |
| Summary: | summary |