The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Discovery Elbow-mosaic Distal Humeral Replacement System.
| Device ID | K033280 |
| 510k Number | K033280 |
| Device Name: | DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM |
| Classification | Prosthesis, Elbow, Constrained, Cemented |
| Applicant | BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JDC |
| CFR Regulation Number | 888.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-10 |
| Decision Date | 2003-12-19 |
| Summary: | summary |
| Biomet Small Diameter Cement Plug Inserter-Sterile | Zimmer Biomet, Inc. | 2019-02-28 |