The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Ascent Knee Revision Femoral Stem.
| Device ID | K001010 |
| 510k Number | K001010 |
| Device Name: | ASCENT KNEE REVISION FEMORAL STEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Tina Lakin |
| Correspondent | Tina Lakin BIOMET, 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 | 2000-03-29 |
| Decision Date | 2000-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304262348 | K001010 | 000 |
| 00880304262188 | K001010 | 000 |
| 00880304262195 | K001010 | 000 |
| 00880304262201 | K001010 | 000 |
| 00880304262225 | K001010 | 000 |
| 00880304262232 | K001010 | 000 |
| 00880304262249 | K001010 | 000 |
| 00880304262256 | K001010 | 000 |
| 00880304262263 | K001010 | 000 |
| 00880304262270 | K001010 | 000 |
| 00880304262287 | K001010 | 000 |
| 00880304262294 | K001010 | 000 |
| 00880304262300 | K001010 | 000 |
| 00880304262317 | K001010 | 000 |
| 00880304262324 | K001010 | 000 |
| 00880304262331 | K001010 | 000 |
| 00880304262171 | K001010 | 000 |