The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Medallion Modular Hip System.
| Device ID | K041850 |
| 510k Number | K041850 |
| Device Name: | MEDALLION MODULAR HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | BIOMET MANUFACTURING, INC. P.O. BOX 587 Warsaw, IN 46581 -0578 |
| Contact | Lonnie Witham |
| Correspondent | Lonnie Witham BIOMET MANUFACTURING, INC. P.O. BOX 587 Warsaw, IN 46581 -0578 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-08 |
| Decision Date | 2004-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304640184 | K041850 | 000 |
| 00880304640016 | K041850 | 000 |
| 00880304640009 | K041850 | 000 |
| 00880304639997 | K041850 | 000 |
| 00880304639980 | K041850 | 000 |
| 00880304639973 | K041850 | 000 |
| 00880304639966 | K041850 | 000 |
| 00880304639959 | K041850 | 000 |
| 00880304639942 | K041850 | 000 |
| 00880304639935 | K041850 | 000 |
| 00880304639928 | K041850 | 000 |
| 00880304639911 | K041850 | 000 |
| 00880304639904 | K041850 | 000 |
| 00880304639898 | K041850 | 000 |
| 00880304640023 | K041850 | 000 |
| 00880304640030 | K041850 | 000 |
| 00880304640047 | K041850 | 000 |
| 00880304640177 | K041850 | 000 |
| 00880304640160 | K041850 | 000 |
| 00880304640153 | K041850 | 000 |
| 00880304640146 | K041850 | 000 |
| 00880304640139 | K041850 | 000 |
| 00880304640122 | K041850 | 000 |
| 00880304640115 | K041850 | 000 |
| 00880304640108 | K041850 | 000 |
| 00880304640092 | K041850 | 000 |
| 00880304640085 | K041850 | 000 |
| 00880304640078 | K041850 | 000 |
| 00880304640061 | K041850 | 000 |
| 00880304640054 | K041850 | 000 |
| 00880304639881 | K041850 | 000 |