The following data is part of a premarket notification filed by Carbofix Orthopedics Ltd. with the FDA for Piccolo Composite(r) Distal Volar Radius Plate System.
| Device ID | K160002 |
| 510k Number | K160002 |
| Device Name: | Piccolo Composite(R) Distal Volar Radius Plate System |
| Classification | Plate, Fixation, Bone |
| Applicant | CARBOFIX ORTHOPEDICS LTD. 11 HA'HOSHLIM STREET Herzeliya, IL 4672411 |
| Contact | Yael Rubin |
| Correspondent | Yael Rubin CARBOFIX ORTHOPEDICS LTD. 11 HA'HOSHLIM STREET Herzeliya, IL 4672411 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-04 |
| Decision Date | 2016-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109339931 | K160002 | 000 |
| 07290109337319 | K160002 | 000 |
| 07290109337326 | K160002 | 000 |
| 07290109337333 | K160002 | 000 |
| 07290109337340 | K160002 | 000 |
| 07290109337357 | K160002 | 000 |
| 07290109339771 | K160002 | 000 |
| 07290109339788 | K160002 | 000 |
| 07290109339924 | K160002 | 000 |
| 07290109337302 | K160002 | 000 |