The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Regenerex Patella Components.
| Device ID | K083782 |
| 510k Number | K083782 |
| Device Name: | REGENEREX PATELLA COMPONENTS |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Susan Alexander |
| Correspondent | Susan Alexander BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. 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 | 2008-12-19 |
| Decision Date | 2009-04-03 |