Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| TWISTOFF® SCREW | 1233-20-012 | Biomet Orthopedics, LLC | HWC | 00887868011207 |
| TWISTOFF® SCREW | 1233-20-013 | Biomet Orthopedics, LLC | HWC | 00887868011214 |
| TWISTOFF® SCREW | 1233-20-011 | Biomet Orthopedics, LLC | HWC | 00887868011191 |
| TWISTOFF ®TWISTOFF SCREW | P2814 | Biomet Orthopedics, LLC | HWC | 00887868116179 |
| TWISTOFF ®TWISTOFF SCREW | P2813 | Biomet Orthopedics, LLC | HWC | 00887868116162 |
| TWISTOFF® SCREW | 1233-20-014 | Biomet Orthopedics, LLC | HWC | 00887868011221 |
| TWISTOFF® SCREW | 1233-20-015 | Biomet Orthopedics, LLC | HWC | 00887868011238 |
| TWISTOFF ®TWISTOFF SCREW | P2812 | Biomet Orthopedics, LLC | HWC | 00887868116155 |
| TWISTOFF ®TWISTOFF SCREW | P2811 | Biomet Orthopedics, LLC | HWC | 00887868116148 |