The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Peri-prosthetic Cable System.
Device ID | K133354 |
510k Number | K133354 |
Device Name: | PERI-PROSTHETIC CABLE SYSTEM |
Classification | Cerclage, Fixation |
Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
Contact | Julie Largent |
Correspondent | Julie Largent BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
Product Code | JDQ |
CFR Regulation Number | 888.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-10-31 |
Decision Date | 2014-01-27 |
Summary: | summary |