The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for Anterior Stabilized Tibial Bearings.
| Device ID | K022586 |
| 510k Number | K022586 |
| Device Name: | ANTERIOR STABILIZED TIBIAL BEARINGS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Dalene T Binkley |
| Correspondent | Dalene T Binkley BIOMET ORTHOPEDICS, 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 | 2002-08-05 |
| Decision Date | 2002-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304265592 | K022586 | 000 |
| 00880304265400 | K022586 | 000 |
| 00880304265394 | K022586 | 000 |
| 00880304265387 | K022586 | 000 |
| 00880304265370 | K022586 | 000 |
| 00880304265356 | K022586 | 000 |
| 00880304265349 | K022586 | 000 |
| 00880304265332 | K022586 | 000 |
| 00880304265325 | K022586 | 000 |
| 00880304265318 | K022586 | 000 |
| 00880304265301 | K022586 | 000 |
| 00880304265295 | K022586 | 000 |
| 00880304265288 | K022586 | 000 |
| 00880304265271 | K022586 | 000 |
| 00880304265264 | K022586 | 000 |
| 00880304265257 | K022586 | 000 |
| 00880304265240 | K022586 | 000 |
| 00880304265417 | K022586 | 000 |
| 00880304265424 | K022586 | 000 |
| 00880304265585 | K022586 | 000 |
| 00880304265578 | K022586 | 000 |
| 00880304265561 | K022586 | 000 |
| 00880304265554 | K022586 | 000 |
| 00880304265547 | K022586 | 000 |
| 00880304265530 | K022586 | 000 |
| 00880304265523 | K022586 | 000 |
| 00880304265516 | K022586 | 000 |
| 00880304265509 | K022586 | 000 |
| 00880304265493 | K022586 | 000 |
| 00880304265486 | K022586 | 000 |
| 00880304265479 | K022586 | 000 |
| 00880304265462 | K022586 | 000 |
| 00880304265455 | K022586 | 000 |
| 00880304265448 | K022586 | 000 |
| 00880304265431 | K022586 | 000 |
| 00880304265233 | K022586 | 000 |