The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Adm And Adm/mdm Duration Inserts, Adm And Adm/mdm X3 Inserts.
| Device ID | K112556 |
| 510k Number | K112556 |
| Device Name: | ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Valerie Giambanco |
| Correspondent | Valerie Giambanco HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-02 |
| Decision Date | 2011-09-28 |
| Summary: | summary |