The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Maestro Carpal Hemiarthroplasty.
| Device ID | K050028 |
| 510k Number | K050028 |
| Device Name: | MAESTRO CARPAL HEMIARTHROPLASTY |
| Classification | Prosthesis, Wrist, Carpal Lunate |
| Applicant | BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Product Code | KWN |
| CFR Regulation Number | 888.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-06 |
| Decision Date | 2005-03-25 |
| Summary: | summary |