The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Ascent Knee System.
| Device ID | K011219 |
| 510k Number | K011219 |
| Device Name: | ASCENT KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Dalene T Binkley |
| Correspondent | Dalene T Binkley BIOMET, INC. 56 EAST BELL DR. 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 | 2001-04-20 |
| Decision Date | 2001-05-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304263925 | K011219 | 000 |
| 00880304263284 | K011219 | 000 |
| 00880304263369 | K011219 | 000 |
| 00880304263376 | K011219 | 000 |
| 00880304263451 | K011219 | 000 |
| 00880304263468 | K011219 | 000 |
| 00880304263499 | K011219 | 000 |
| 00880304263505 | K011219 | 000 |
| 00880304263574 | K011219 | 000 |
| 00880304263581 | K011219 | 000 |
| 00880304263659 | K011219 | 000 |
| 00880304263666 | K011219 | 000 |
| 00880304263758 | K011219 | 000 |
| 00880304263765 | K011219 | 000 |
| 00880304263833 | K011219 | 000 |
| 00880304263840 | K011219 | 000 |
| 00880304263918 | K011219 | 000 |
| 00880304263277 | K011219 | 000 |