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 |