Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K182015
Piccolo Composite® Plate System · CarboFix Orthopedics , Ltd. · decided 2018-10-11 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Piccolo Composite Plate System | Non-Locking Screw | CARBOFIX ORTHOPEDICS LTD | HRS KTT | 07290110201456 |
| Piccolo Composite Plate System | Cannulated Screw | CARBOFIX ORTHOPEDICS LTD | HRS | 07290110201241 |
| Piccolo Composite Plate System | Locking Screw | CARBOFIX ORTHOPEDICS LTD | HRS KTT | 07290109334660 |
| Piccolo Composite Plate System | Locking Screw | CARBOFIX ORTHOPEDICS LTD | HRS KTT | 07290109334677 |
| Piccolo Composite Plate System | Cannulated Screw | CARBOFIX ORTHOPEDICS LTD | HRS | 07290110201265 |
| Piccolo Composite Plate System | Non-Locking Screw | CARBOFIX ORTHOPEDICS LTD | HRS KTT | 07290109334721 |
| Piccolo Composite Plate System | Cannulated Screw | CARBOFIX ORTHOPEDICS LTD | HRS | 07290110201234 |
| Piccolo Composite Plate System | Cannulated Screw | CARBOFIX ORTHOPEDICS LTD | HRS | 07290110201289 |
| Piccolo Composite Plate System | Non-Locking Screw | CARBOFIX ORTHOPEDICS LTD | HRS KTT | 07290109334714 |
| Piccolo Composite Plate System | Locking Screw | CARBOFIX ORTHOPEDICS LTD | HRS KTT | 07290109334608 |
| Piccolo Composite Plate System | Template - Flat | CARBOFIX ORTHOPEDICS LTD | HRS | 07290110205096 |
| Piccolo Composite Plate System | Locking Screw | CARBOFIX ORTHOPEDICS LTD | HRS KTT | 07290110201432 |
| Piccolo Composite Plate System | Template - 2.0 mm | CARBOFIX ORTHOPEDICS LTD | HRS | 07290110205119 |
| Piccolo Composite Plate System | Lapidus Plate | CARBOFIX ORTHOPEDICS LTD | HRS | 07290110205072 |
| Piccolo Composite Plate System | Locking Screw | CARBOFIX ORTHOPEDICS LTD | HRS KTT | 07290110201449 |
| Piccolo Composite Plate System | Locking Screw | CARBOFIX ORTHOPEDICS LTD | HRS KTT | 07290109334615 |
| Piccolo Composite Plate System | Cannulated Screw | CARBOFIX ORTHOPEDICS LTD | HRS | 07290110201296 |
| Piccolo Composite Plate System | Lapidus Plate | CARBOFIX ORTHOPEDICS LTD | HRS | 07290110205058 |
| Piccolo Composite Plate System | Cannulated Screw | CARBOFIX ORTHOPEDICS LTD | HRS | 07290110201258 |
| Piccolo Composite Plate System | Lapidus Plate | CARBOFIX ORTHOPEDICS LTD | HRS | 07290110205065 |
| Piccolo Composite Plate System | Locking Screw | CARBOFIX ORTHOPEDICS LTD | HRS KTT | 07290109334639 |
| Piccolo Composite Plate System | Locking Screw | CARBOFIX ORTHOPEDICS LTD | HRS KTT | 07290109334622 |
| Piccolo Composite Plate System | Non-Locking Screw | CARBOFIX ORTHOPEDICS LTD | HRS KTT | 07290110201463 |
| Piccolo Composite Plate System | Non-Locking Screw | CARBOFIX ORTHOPEDICS LTD | HRS KTT | 07290109334745 |
| Piccolo Composite Plate System | Non-Locking Screw | CARBOFIX ORTHOPEDICS LTD | HRS KTT | 07290109334707 |