The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Tritanium Peri-apatitie Acetabular Solid-backed Shell, Tritanium Peri-apatite.
| Device ID | K101072 |
| 510k Number | K101072 |
| Device Name: | TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Karen Ariemma |
| Correspondent | Karen Ariemma HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | LPH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-19 |
| Decision Date | 2011-04-11 |
| Summary: | summary |