The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Ascent Knee System.
| Device ID | K993111 |
| 510k Number | K993111 |
| Device Name: | ASCENT KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | BIOMET MANUFACTURING, INC. AIRPORT INDUSTRIAL PARK P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Mary Verstynen |
| Correspondent | Mary Verstynen BIOMET MANUFACTURING, INC. AIRPORT INDUSTRIAL PARK 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 | 1999-09-17 |
| Decision Date | 1999-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304259683 | K993111 | 000 |
| 00880304259676 | K993111 | 000 |
| 00880304259669 | K993111 | 000 |
| 00880304259645 | K993111 | 000 |
| 00880304259614 | K993111 | 000 |
| 00880304259607 | K993111 | 000 |
| 00880304259591 | K993111 | 000 |
| 00880304259577 | K993111 | 000 |