The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Recovery Protrusio Cage.
| Device ID | K971890 |
| 510k Number | K971890 |
| Device Name: | RECOVERY PROTRUSIO CAGE |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Deborah M Matarazzo |
| Correspondent | Deborah M Matarazzo 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 | 1997-05-22 |
| Decision Date | 1997-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304225206 | K971890 | 000 |
| 00880304204126 | K971890 | 000 |
| 00880304204119 | K971890 | 000 |
| 00880304007338 | K971890 | 000 |
| 00880304004856 | K971890 | 000 |
| 00880304004849 | K971890 | 000 |
| 00880304004832 | K971890 | 000 |
| 00880304004825 | K971890 | 000 |
| 00880304004818 | K971890 | 000 |
| 00880304004801 | K971890 | 000 |
| 00880304004795 | K971890 | 000 |
| 00880304004788 | K971890 | 000 |
| 00880304004771 | K971890 | 000 |
| 00880304004757 | K971890 | 000 |
| 00880304004740 | K971890 | 000 |
| 00880304204133 | K971890 | 000 |
| 00880304225053 | K971890 | 000 |
| 00880304225190 | K971890 | 000 |
| 00880304225183 | K971890 | 000 |
| 00880304225176 | K971890 | 000 |
| 00880304225169 | K971890 | 000 |
| 00880304225152 | K971890 | 000 |
| 00880304225145 | K971890 | 000 |
| 00880304225138 | K971890 | 000 |
| 00880304225121 | K971890 | 000 |
| 00880304225114 | K971890 | 000 |
| 00880304225107 | K971890 | 000 |
| 00880304225091 | K971890 | 000 |
| 00880304225084 | K971890 | 000 |
| 00880304225077 | K971890 | 000 |
| 00880304225060 | K971890 | 000 |
| 00880304000858 | K971890 | 000 |