The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Porous Coated Discovery Elbow.
| Device ID | K051975 |
| 510k Number | K051975 |
| Device Name: | POROUS COATED DISCOVERY ELBOW |
| Classification | Prosthesis, Elbow, Constrained, Cemented |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JDC |
| CFR Regulation Number | 888.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-21 |
| Decision Date | 2005-09-06 |
| Summary: | summary |