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 |