The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Maxim Accel (vanguard) Ps+ Bearings.
| Device ID | K041046 |
| 510k Number | K041046 |
| Device Name: | MAXIM ACCEL (VANGUARD) PS+ BEARINGS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46582 |
| Contact | Tracy J Bickel |
| Correspondent | Tracy J Bickel BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46582 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-22 |
| Decision Date | 2004-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304439269 | K041046 | 000 |
| 00880304437272 | K041046 | 000 |
| 00880304437319 | K041046 | 000 |
| 00880304437326 | K041046 | 000 |
| 00880304437333 | K041046 | 000 |
| 00880304437340 | K041046 | 000 |
| 00880304437463 | K041046 | 000 |
| 00880304437524 | K041046 | 000 |
| 00880304438224 | K041046 | 000 |
| 00880304437265 | K041046 | 000 |
| 00880304437227 | K041046 | 000 |
| 00880304437081 | K041046 | 000 |
| 00880304437098 | K041046 | 000 |
| 00880304437111 | K041046 | 000 |
| 00880304437173 | K041046 | 000 |
| 00880304437180 | K041046 | 000 |
| 00880304437197 | K041046 | 000 |
| 00880304437203 | K041046 | 000 |
| 00880304437210 | K041046 | 000 |
| 00880304438262 | K041046 | 000 |
| 00880304438347 | K041046 | 000 |
| 00880304438835 | K041046 | 000 |
| 00880304438842 | K041046 | 000 |
| 00880304438897 | K041046 | 000 |
| 00880304438903 | K041046 | 000 |
| 00880304438989 | K041046 | 000 |
| 00880304438996 | K041046 | 000 |
| 00880304439009 | K041046 | 000 |
| 00880304439238 | K041046 | 000 |
| 00880304438828 | K041046 | 000 |
| 00880304438811 | K041046 | 000 |
| 00880304438354 | K041046 | 000 |
| 00880304438361 | K041046 | 000 |
| 00880304438378 | K041046 | 000 |
| 00880304438385 | K041046 | 000 |
| 00880304438545 | K041046 | 000 |
| 00880304438552 | K041046 | 000 |
| 00880304438569 | K041046 | 000 |
| 00880304438576 | K041046 | 000 |
| 00880304437074 | K041046 | 000 |