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 |