The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Rx 90 Acetabular Component System.
| Device ID | K920639 |
| 510k Number | K920639 |
| Device Name: | RX 90 ACETABULAR COMPONENT SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Contact | Dutch Harrison |
| Correspondent | Dutch Harrison 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 | 1992-02-12 |
| Decision Date | 1992-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304311060 | K920639 | 000 |
| 00880304311053 | K920639 | 000 |
| 00880304311046 | K920639 | 000 |
| 00880304311039 | K920639 | 000 |
| 00880304311022 | K920639 | 000 |
| 00880304311015 | K920639 | 000 |
| 00880304311008 | K920639 | 000 |