The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Versa-dial Humeral Head.
| Device ID | K040610 |
| 510k Number | K040610 |
| Device Name: | VERSA-DIAL HUMERAL HEAD |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | BIOMET MANUFACTURING, INC. P.O. BOX 587 Warsaw, IN 46581 -0578 |
| Contact | Gary Baker |
| Correspondent | Gary Baker BIOMET MANUFACTURING, INC. P.O. BOX 587 Warsaw, IN 46581 -0578 |
| Product Code | KWS |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWT |
| Subsequent Product Code | MBF |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-08 |
| Decision Date | 2004-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304460812 | K040610 | 000 |
| 00880304460751 | K040610 | 000 |
| 00880304212244 | K040610 | 000 |
| 00880304212237 | K040610 | 000 |
| 00880304212220 | K040610 | 000 |
| 00880304212213 | K040610 | 000 |
| 00880304212206 | K040610 | 000 |
| 00880304212190 | K040610 | 000 |
| 00880304212183 | K040610 | 000 |