The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Modification To Modular Replacement System (mrs) Humeral Stems.
| Device ID | K040128 |
| 510k Number | K040128 |
| Device Name: | MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Margaret F Crowe |
| Correspondent | Margaret F Crowe HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-21 |
| Decision Date | 2004-03-26 |
| Summary: | summary |