The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Vanguard Removable Molded Poly Tibia.
Device ID | K102580 |
510k Number | K102580 |
Device Name: | VANGUARD REMOVABLE MOLDED POLY TIBIA |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46580 |
Contact | Tamara J West |
Correspondent | Tamara J West BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46580 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-08 |
Decision Date | 2011-03-03 |
Summary: | summary |