The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Ti-max Protrusio Cage.
| Device ID | K001376 |
| 510k Number | K001376 |
| Device Name: | TI-MAX PROTRUSIO CAGE |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Tracy J Bickel |
| Correspondent | Tracy J Bickel BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-01 |
| Decision Date | 2000-07-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304225602 | K001376 | 000 |
| 00880304225596 | K001376 | 000 |
| 00880304225565 | K001376 | 000 |
| 00880304225220 | K001376 | 000 |