The following data is part of a premarket notification filed by Carbofix Orthopedics Ltd. with the FDA for Piccolo Composite Ankle Arthrodesis Nailing System.
| Device ID | K123810 |
| 510k Number | K123810 |
| Device Name: | PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | CARBOFIX ORTHOPEDICS LTD. 11 HA'HOSHLIM STREET Herzeliya, IL 46724 |
| Contact | Yael Rubin |
| Correspondent | Yael Rubin CARBOFIX ORTHOPEDICS LTD. 11 HA'HOSHLIM STREET Herzeliya, IL 46724 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-11 |
| Decision Date | 2013-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110200985 | K123810 | 000 |
| 07290110200831 | K123810 | 000 |
| 07290110200824 | K123810 | 000 |
| 07290110200817 | K123810 | 000 |
| 07290109338767 | K123810 | 000 |
| 07290109338545 | K123810 | 000 |
| 07290109335575 | K123810 | 000 |
| 07290109335568 | K123810 | 000 |
| 07290109332741 | K123810 | 000 |
| 07290109332734 | K123810 | 000 |
| 07290109332727 | K123810 | 000 |
| 07290110200848 | K123810 | 000 |
| 07290110200855 | K123810 | 000 |
| 07290110200862 | K123810 | 000 |
| 07290110200978 | K123810 | 000 |
| 07290110200961 | K123810 | 000 |
| 07290110200954 | K123810 | 000 |
| 07290110200947 | K123810 | 000 |
| 07290110200930 | K123810 | 000 |
| 07290110200923 | K123810 | 000 |
| 07290110200909 | K123810 | 000 |
| 07290110200893 | K123810 | 000 |
| 07290110200886 | K123810 | 000 |
| 07290110200879 | K123810 | 000 |
| 07290109332697 | K123810 | 000 |