The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Ascent Knee System.
| Device ID | K991428 |
| 510k Number | K991428 |
| Device Name: | ASCENT KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Dalene Hufziger Binkley |
| Correspondent | Dalene Hufziger Binkley BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-26 |
| Decision Date | 1999-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304262362 | K991428 | 000 |
| 00880304262553 | K991428 | 000 |
| 00880304262560 | K991428 | 000 |
| 00880304262584 | K991428 | 000 |
| 00880304262591 | K991428 | 000 |
| 00880304262638 | K991428 | 000 |
| 00880304262645 | K991428 | 000 |
| 00880304262652 | K991428 | 000 |
| 00880304262676 | K991428 | 000 |
| 00880304262546 | K991428 | 000 |
| 00880304262508 | K991428 | 000 |
| 00880304262379 | K991428 | 000 |
| 00880304262386 | K991428 | 000 |
| 00880304262409 | K991428 | 000 |
| 00880304262416 | K991428 | 000 |
| 00880304262454 | K991428 | 000 |
| 00880304262461 | K991428 | 000 |
| 00880304262478 | K991428 | 000 |
| 00880304262492 | K991428 | 000 |
| 00880304262683 | K991428 | 000 |
| 00880304262720 | K991428 | 000 |
| 00880304262737 | K991428 | 000 |
| 00880304262904 | K991428 | 000 |
| 00880304262911 | K991428 | 000 |
| 00880304262928 | K991428 | 000 |
| 00880304262966 | K991428 | 000 |
| 00880304262973 | K991428 | 000 |
| 00880304262980 | K991428 | 000 |
| 00880304262997 | K991428 | 000 |
| 00880304263000 | K991428 | 000 |
| 00880304262898 | K991428 | 000 |
| 00880304262881 | K991428 | 000 |
| 00880304262744 | K991428 | 000 |
| 00880304262751 | K991428 | 000 |
| 00880304262768 | K991428 | 000 |
| 00880304262805 | K991428 | 000 |
| 00880304262812 | K991428 | 000 |
| 00880304262829 | K991428 | 000 |
| 00880304262836 | K991428 | 000 |
| 00880304262843 | K991428 | 000 |
| 00880304263031 | K991428 | 000 |