The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for The New Bio-moore Endo Heads.
| Device ID | K984028 |
| 510k Number | K984028 |
| Device Name: | THE NEW BIO-MOORE ENDO HEADS |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Tracey J Bickel |
| Correspondent | Tracey J Bickel BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-12 |
| Decision Date | 1999-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304221918 | K984028 | 000 |
| 00880304221758 | K984028 | 000 |
| 00880304221734 | K984028 | 000 |
| 00880304221727 | K984028 | 000 |
| 00880304221710 | K984028 | 000 |
| 00880304221703 | K984028 | 000 |
| 00880304221697 | K984028 | 000 |
| 00880304007499 | K984028 | 000 |
| 00880304001565 | K984028 | 000 |
| 00880304221772 | K984028 | 000 |
| 00880304221802 | K984028 | 000 |
| 00880304221819 | K984028 | 000 |
| 00880304221901 | K984028 | 000 |
| 00880304221895 | K984028 | 000 |
| 00880304221888 | K984028 | 000 |
| 00880304221871 | K984028 | 000 |
| 00880304221857 | K984028 | 000 |
| 00880304221840 | K984028 | 000 |
| 00880304221833 | K984028 | 000 |
| 00880304221826 | K984028 | 000 |
| 00880304221789 | K984028 | 000 |