The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Versa-dial Humeral Head Prosthesis.
| Device ID | K060716 |
| 510k Number | K060716 |
| Device Name: | VERSA-DIAL HUMERAL HEAD PROSTHESIS |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Susan Alexander |
| Correspondent | Susan Alexander BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | MBF |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| CFR Regulation Number | 888.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-17 |
| Decision Date | 2006-06-12 |
| Summary: | summary |