The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Ascent Knee System.
| Device ID | K994326 |
| 510k Number | K994326 |
| Device Name: | ASCENT KNEE SYSTEM |
| Classification | Prosthesis, Toe, Constrained, Polymer |
| Applicant | BIOMET MANUFACTURING, INC. AIRPORT INDUSTRIAL PARK P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Tracy J Bickel |
| Correspondent | Tracy J Bickel BIOMET MANUFACTURING, INC. AIRPORT INDUSTRIAL PARK P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KWH |
| CFR Regulation Number | 888.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-22 |
| Decision Date | 2000-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304263017 | K994326 | 000 |
| 00880304000896 | K994326 | 000 |
| 00880304262423 | K994326 | 000 |
| 00880304262515 | K994326 | 000 |
| 00880304262607 | K994326 | 000 |
| 00880304262690 | K994326 | 000 |
| 00880304262775 | K994326 | 000 |
| 00880304262850 | K994326 | 000 |
| 00880304262935 | K994326 | 000 |
| 00880304000285 | K994326 | 000 |