The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Ascent Porous Open Box Ps Component/ascent Posterior Stabalized (ps) Distal Femoral Pegs.
Device ID | K041872 |
510k Number | K041872 |
Device Name: | ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGS |
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 | Patricia Sandborn Beres |
Correspondent | Patricia Sandborn Beres 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 | 2004-07-09 |
Decision Date | 2004-09-08 |
Summary: | summary |