The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Regenerex Tibial Components.
| Device ID | K080361 |
| 510k Number | K080361 |
| Device Name: | REGENEREX TIBIAL COMPONENTS |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Susan Alexander |
| Correspondent | Susan Alexander BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-11 |
| Decision Date | 2008-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304497092 | K080361 | 000 |
| 00880304463585 | K080361 | 000 |
| 00880304463592 | K080361 | 000 |
| 00880304463608 | K080361 | 000 |
| 00880304463615 | K080361 | 000 |
| 00880304463622 | K080361 | 000 |
| 00880304463639 | K080361 | 000 |
| 00880304463646 | K080361 | 000 |
| 00880304478145 | K080361 | 000 |
| 00880304479920 | K080361 | 000 |
| 00880304495227 | K080361 | 000 |
| 00887868252204 | K080361 | 000 |