The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Ranawat/burstein Porous Total Hip Femoral Comp.
| Device ID | K911685 |
| 510k Number | K911685 |
| Device Name: | RANAWAT/BURSTEIN POROUS TOTAL HIP FEMORAL COMP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Contact | Patricia M Sandborn |
| Correspondent | Patricia M Sandborn BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK 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 | 1991-04-16 |
| Decision Date | 1991-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304256873 | K911685 | 000 |
| 00887868310805 | K911685 | 000 |
| 00887868310812 | K911685 | 000 |
| 00887868310829 | K911685 | 000 |
| 00887868310836 | K911685 | 000 |
| 00887868310850 | K911685 | 000 |
| 00887868310874 | K911685 | 000 |
| 00880304256767 | K911685 | 000 |
| 00880304256798 | K911685 | 000 |
| 00880304256811 | K911685 | 000 |
| 00880304256828 | K911685 | 000 |
| 00880304256835 | K911685 | 000 |
| 00880304256859 | K911685 | 000 |
| 00887868310782 | K911685 | 000 |