The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Ringloc 36mm Line And Modular Femoral Heads.
| Device ID | K032396 |
| 510k Number | K032396 |
| Device Name: | RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Gary Baker |
| Correspondent | Gary Baker BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-04 |
| Decision Date | 2003-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304221024 | K032396 | 000 |
| 00887868307997 | K032396 | 000 |
| 00887868307980 | K032396 | 000 |
| 00887868307973 | K032396 | 000 |
| 00887868307966 | K032396 | 000 |
| 00887868307959 | K032396 | 000 |
| 00887868307942 | K032396 | 000 |
| 00887868307935 | K032396 | 000 |
| 00887868264559 | K032396 | 000 |
| 00887868264542 | K032396 | 000 |
| 00887868264535 | K032396 | 000 |
| 00887868264528 | K032396 | 000 |
| 00887868264511 | K032396 | 000 |
| 00887868264504 | K032396 | 000 |
| 00887868342790 | K032396 | 000 |
| 00887868342806 | K032396 | 000 |
| 00887868342813 | K032396 | 000 |
| 00880304221017 | K032396 | 000 |
| 00880304221000 | K032396 | 000 |
| 00880304220997 | K032396 | 000 |
| 00880304220980 | K032396 | 000 |
| 00880304210561 | K032396 | 000 |
| 00880304210554 | K032396 | 000 |
| 00880304210547 | K032396 | 000 |
| 00880304210530 | K032396 | 000 |
| 00880304210523 | K032396 | 000 |
| 00880304210516 | K032396 | 000 |
| 00880304210509 | K032396 | 000 |
| 00887868342837 | K032396 | 000 |
| 00887868342820 | K032396 | 000 |
| 00887868264498 | K032396 | 000 |