The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Tri-polar System.
| Device ID | K991990 |
| 510k Number | K991990 |
| Device Name: | TRI-POLAR SYSTEM |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Michelle L Mckinley |
| Correspondent | Michelle L Mckinley BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-14 |
| Decision Date | 1999-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304209633 | K991990 | 000 |
| 00880304209473 | K991990 | 000 |
| 00880304209466 | K991990 | 000 |
| 00880304209459 | K991990 | 000 |
| 00880304209442 | K991990 | 000 |
| 00880304209435 | K991990 | 000 |
| 00880304209428 | K991990 | 000 |
| 00880304209411 | K991990 | 000 |
| 00880304209404 | K991990 | 000 |
| 00880304209398 | K991990 | 000 |
| 00880304209381 | K991990 | 000 |
| 00880304209374 | K991990 | 000 |
| 00880304209497 | K991990 | 000 |
| 00880304209503 | K991990 | 000 |
| 00880304209626 | K991990 | 000 |
| 00880304209619 | K991990 | 000 |
| 00880304209602 | K991990 | 000 |
| 00880304209589 | K991990 | 000 |
| 00880304209572 | K991990 | 000 |
| 00880304209565 | K991990 | 000 |
| 00880304209558 | K991990 | 000 |
| 00880304209541 | K991990 | 000 |
| 00880304209534 | K991990 | 000 |
| 00880304209527 | K991990 | 000 |
| 00880304209510 | K991990 | 000 |
| 00880304209367 | K991990 | 000 |