The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Maxim Accel Knee System.
Device ID | K023546 |
510k Number | K023546 |
Device Name: | MAXIM ACCEL KNEE SYSTEM |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
Contact | Tracy J Bickel |
Correspondent | Tracy J Bickel BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-22 |
Decision Date | 2003-01-17 |
Summary: | summary |