The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Biomet Cable System.
Device ID | K071271 |
510k Number | K071271 |
Device Name: | BIOMET CABLE SYSTEM |
Classification | Cerclage, Fixation |
Applicant | BIOMET MANUFACTURING, INC. P.O. BOX 587 Warsaw, IN 46581 -0578 |
Contact | Becky Earl |
Correspondent | Becky Earl BIOMET MANUFACTURING, INC. P.O. BOX 587 Warsaw, IN 46581 -0578 |
Product Code | JDQ |
CFR Regulation Number | 888.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-05-07 |
Decision Date | 2007-10-23 |
Summary: | summary |