The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Biomet's Minimally Constrained Elbow.
| Device ID | K003253 |
| 510k Number | K003253 |
| Device Name: | BIOMET'S MINIMALLY CONSTRAINED ELBOW |
| Classification | Prosthesis, Elbow, Constrained, Cemented |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Sara A Bailey |
| Correspondent | Sara A Bailey BIOMET, INC. AIRPORT INDUSTRIAL PARK, 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 | 2000-10-17 |
| Decision Date | 2001-01-12 |