The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Freedom Constrained Liners.
| Device ID | K030047 |
| 510k Number | K030047 |
| Device Name: | FREEDOM CONSTRAINED LINERS |
| Classification | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer |
| Applicant | BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Max T Hebel |
| Correspondent | Max T Hebel BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KWZ |
| CFR Regulation Number | 888.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-06 |
| Decision Date | 2003-01-23 |
| Summary: | summary |