The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Biomet Cannulated Screw System.
Device ID | K140891 |
510k Number | K140891 |
Device Name: | BIOMET CANNULATED SCREW SYSTEM |
Classification | Screw, Fixation, Bone |
Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
Contact | Victoria Scheitlin |
Correspondent | Victoria Scheitlin BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-04-08 |
Decision Date | 2014-06-03 |
Summary: | summary |