Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K140390
TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS · Biomet Manufacturing Corp · decided 2014-09-10 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Comprehensive Shoulder System | TI-113046 | Biomet Orthopedics, LLC | HSD KWS KWT MBF | 00880304681088 |
| Comprehensive Shoulder System | TI-113048 | Biomet Orthopedics, LLC | HSD KWS KWT MBF | 00880304681095 |
| COMPREHENSIVE® SHOULDER INSTRUMENTS | 41-406804 | Biomet Orthopedics, LLC | HSD KWS KWT MBF | 00880304452992 |
| Comprehensive Shoulder System | TI-113042 | Biomet Orthopedics, LLC | HSD KWS KWT MBF | 00880304681064 |
| COMPREHENSIVE® SHOULDER INSTRUMENTS | 41-406815 | Biomet Orthopedics, LLC | HSD KWS KWT MBF | 00880304451018 |
| Comprehensive® Shoulder Instruments | 41-406808 | Biomet Orthopedics, LLC | HSD KWS KWT MBF | 00887868506536 |
| Comprehensive® Shoulder Instruments | 41-406812 | Biomet Orthopedics, LLC | HSD KWS KWT MBF | 00887868506574 |
| COMPREHENSIVE® SHOULDER INSTRUMENTS | 41-406809 | Biomet Orthopedics, LLC | HSD KWS KWT MBF | 00880304450950 |
| Comprehensive Shoulder System | TI-113024 | Biomet Orthopedics, LLC | HSD KWS KWT MBF | 00880304681026 |
| Comprehensive® Shoulder Instruments | 41-406807 | Biomet Orthopedics, LLC | HSD KWS KWT MBF | 00887868506529 |
| COMPREHENSIVE® SHOULDER INSTRUMENTS | 41-406814 | Biomet Orthopedics, LLC | HSD KWS KWT MBF | 00880304451001 |
| Comprehensive Shoulder System | TI-113032 | Biomet Orthopedics, LLC | HSD KWS KWT MBF | 00880304681033 |
| COMPREHENSIVE® SHOULDER INSTRUMENTS | 41-406807 | Biomet Orthopedics, LLC | HSD KWS KWT MBF | 00880304450936 |
| Comprehensive® Shoulder Instruments | 41-406806 | Biomet Orthopedics, LLC | HSD KWS KWT MBF | 00887868506512 |
| COMPREHENSIVE® SHOULDER INSTRUMENTS | 41-406813 | Biomet Orthopedics, LLC | HSD KWS KWT MBF | 00880304450998 |
| Comprehensive Shoulder System | TI-113053 | Biomet Orthopedics, LLC | HSD KWS KWT MBF | 00880304681101 |
| Comprehensive® Shoulder Instruments | 41-406814 | Biomet Orthopedics, LLC | HSD KWS KWT MBF | 00887868506598 |
| Comprehensive Shoulder System | TI-113044 | Biomet Orthopedics, LLC | HSD KWS KWT MBF | 00880304681071 |
| COMPREHENSIVE® SHOULDER INSTRUMENTS | 41-406806 | Biomet Orthopedics, LLC | HSD KWS KWT MBF | 00880304450929 |
| Comprehensive Shoulder System | TI-113036 | Biomet Orthopedics, LLC | HSD KWS KWT MBF | 00880304681057 |
| Comprehensive® Shoulder Instruments | 41-406809 | Biomet Orthopedics, LLC | HSD KWS KWT MBF | 00887868506543 |
| Comprehensive® Shoulder Instruments | 41-406818 | Biomet Orthopedics, LLC | HSD KWS KWT MBF | 00887868506635 |
| Comprehensive® Shoulder Instruments | 41-406811 | Biomet Orthopedics, LLC | HSD KWS KWT MBF | 00887868506567 |
| COMPREHENSIVE® SHOULDER INSTRUMENTS | 41-406818 | Biomet Orthopedics, LLC | HSD KWS KWT MBF | 00880304456617 |
| Comprehensive® Shoulder Instruments | 41-406813 | Biomet Orthopedics, LLC | HSD KWS KWT MBF | 00887868506581 |