The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Ascent Xxl Open Box Femoral Component.
| Device ID | K002735 |
| 510k Number | K002735 |
| Device Name: | ASCENT XXL OPEN BOX FEMORAL COMPONENT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Michelle L Mckinley |
| Correspondent | Michelle L Mckinley 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 | 2000-09-01 |
| Decision Date | 2000-09-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304000926 | K002735 | 000 |
| 00880304000902 | K002735 | 000 |