Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K130033
TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO · Biomet Manufacturing Corp · decided 2013-08-01 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ToggleLoc™ With Ziploop™ | 909849 | Biomet Orthopedics, LLC | JDR MBI | 00880304979598 |
| ToggleLoc | 904721 | Biomet Orthopedics, LLC | JDR MBI | 00880304453272 |
| ToggleLoc | 904722 | Biomet Orthopedics, LLC | JDR MBI | 00880304453289 |
| ToggleLoc | 904724 | Biomet Orthopedics, LLC | JDR MBI | 00880304453302 |
| ZIPTIGHT FIXATION SYSTEM | 909853 | Biomet Orthopedics, LLC | JDR MBI | 00880304476097 |
| TOGGLELOC WITH ZIPLOOP | 909874 | Biomet Sports Medicine, LLC | JDR MBI | 00880304478923 |
| ToggleLoc | 904727 | Biomet Orthopedics, LLC | JDR MBI | 00880304453333 |
| ToggleLoc | 904726 | Biomet Orthopedics, LLC | JDR MBI | 00880304453326 |
| ToggleLoc | 904723 | Biomet Orthopedics, LLC | JDR MBI | 00880304453296 |
| ToggleLoc with Ziploop | 904753 | Biomet Orthopedics, LLC | JDR MBI | 00880304469471 |
| ZIPTIGHT FIXATION SYSTEM | 909856 | Biomet Orthopedics, LLC | JDR MBI | 00880304473560 |
| ZIPTIGHT FIXATION SYSTEM | 909857 | Biomet Orthopedics, LLC | JDR MBI | 00880304475854 |
| ToggleLoc With Ziploop | 904754 | Biomet Orthopedics, LLC | JDR MBI | 00880304464858 |
| ZIPTIGHT | 904835 | Biomet Orthopedics, LLC | JDR MBI | 00880304478824 |
| ToggleLoc | 904725 | Biomet Orthopedics, LLC | JDR MBI | 00880304453319 |
| ToggleLoc With Ziploop | 904756 | Biomet Orthopedics, LLC | JDR MBI | 00880304464223 |
| ToggleLoc® with ZipLoop® | 909848 | Biomet Orthopedics, LLC | JDR MBI | 00887868572531 |
| ToggleLoc™ With Ziploop™ | 909848 | Biomet Orthopedics, LLC | JDR MBI | 00880304979581 |
| TOGGLELOC WITH ZIPLOOP | 909848 | Biomet Sports Medicine, LLC | JDR MBI | 00880304464773 |
| TOGGLELOC XL WITH ZIPLOOP | 110005089 | Biomet Orthopedics, LLC | JDR MBI | 00880304567641 |
| ToggleLoc® with ZipLoop® | 909849 | Biomet Orthopedics, LLC | JDR MBI | 00887868572548 |
| ToggleLoc | 904720 | Biomet Orthopedics, LLC | JDR MBI | 00880304453265 |
| TOGGLELOC™ WITH ZIPLOOP™ | 909874 | Biomet Orthopedics, LLC | JDR MBI | 00880304863422 |
| ZIPTIGHT FIXATION SYSTEM | 904759 | Biomet Orthopedics, LLC | JDR MBI | 00880304476103 |
| ToggleLoc With Ziploop | 904755 | Biomet Orthopedics, LLC | JDR MBI | 00880304453364 |