Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K182516
Comprehensive Nano Stemless Shoulder · Biomet Manufacturing Corp · decided 2019-04-22 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| COMPREHENSIVE SHOULDER SYSTEM | 31-406938 | Biomet Orthopedics, LLC | PKC | 00880304539693 |
| COMPREHENSIVE SHOULDER SYSTEM | 31-406929 | Biomet Orthopedics, LLC | PKC | 00880304677449 |
| Comprehensive® Shoulder System | 31-406950 | Biomet Orthopedics, LLC | PKC | 00887868479649 |
| Comprehensive® Shoulder System | US-115736 | Biomet Orthopedics, LLC | PKC | 00887868264016 |
| COMPREHENSIVE SHOULDER SYSTEM | 31-406917 | Biomet Orthopedics, LLC | PKC | 00880304538580 |
| COMPREHENSIVE SHOULDER SYSTEM | 31-406991 | Biomet Orthopedics, LLC | PKC | 00880304539860 |
| Comprehensive® Shoulder System | 31-406958 | Biomet Orthopedics, LLC | PKC | 00887868479687 |
| Comprehensive® Shoulder System | 31-406995 | Biomet Orthopedics, LLC | PKC | 00887868479793 |
| Comprehensive® Shoulder System | 31-406938 | Biomet Orthopedics, LLC | PKC | 00887868479564 |
| Comprehensive® Shoulder System | 31-406984 | Biomet Orthopedics, LLC | PKC | 00887868479748 |
| COMPREHENSIVE SHOULDER SYSTEM | 31-406942 | Biomet Orthopedics, LLC | PKC | 00880304539808 |
| Comprehensive® Shoulder System | 31-406976 | Biomet Orthopedics, LLC | PKC | 00887868479724 |
| Comprehensive® Shoulder System | 31-406932 | Biomet Orthopedics, LLC | PKC | 00887868479533 |
| Comprehensive® Shoulder System | 31-406994 | Biomet Orthopedics, LLC | PKC | 00887868479786 |
| Comprehensive® Shoulder System | 31-406960 | Biomet Orthopedics, LLC | PKC | 00887868479694 |
| Comprehensive® Shoulder System | 31-406917 | Biomet Orthopedics, LLC | PKC | 00887868525629 |
| Comprehensive® Shoulder System | 31-406972 | Biomet Orthopedics, LLC | PKC | 00887868479717 |
| Comprehensive® Shoulder System | 31-406943 | Biomet Orthopedics, LLC | PKC | 00887868479601 |
| COMPREHENSIVE SHOULDER SYSTEM | 31-406932 | Biomet Orthopedics, LLC | PKC | 00880304539631 |
| COMPREHENSIVE SHOULDER SYSTEM | 31-406998 | Biomet Orthopedics, LLC | PKC | 00880304539785 |
| COMPREHENSIVE SHOULDER SYSTEM | 31-406968 | Biomet Orthopedics, LLC | PKC | 00880304539679 |
| COMPREHENSIVE SHOULDER SYSTEM | 31-406954 | Biomet Orthopedics, LLC | PKC | 00880304539730 |
| Comprehensive® Shoulder System | 31-406944 | Biomet Orthopedics, LLC | PKC | 00887868479618 |
| COMPREHENSIVE SHOULDER SYSTEM | 31-406995 | Biomet Orthopedics, LLC | PKC | 00880304539723 |
| Comprehensive® Shoulder System | 31-406919 | Biomet Orthopedics, LLC | PKC | 00887868525636 |