Piccolo Composite® Nailing System
Rod, Fixation, Intramedullary And Accessories
CARBOFIX ORTHOPEDICS, LTD.
The following data is part of a premarket notification filed by Carbofix Orthopedics, Ltd. with the FDA for Piccolo Composite® Nailing System.
Pre-market Notification Details
| Device ID | K153536 |
| 510k Number | K153536 |
| Device Name: | Piccolo Composite® Nailing System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | CARBOFIX ORTHOPEDICS, LTD. 11 HA'HOSHLIM ST. Herzeliya, IL 4627411 |
| Contact | Yael Rubin |
| Correspondent | Yael Rubin CARBOFIX ORTHOPEDICS, LTD. 11 HA'HOSHLIM ST. Herzeliya, IL 4627411 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-10 |
| Decision Date | 2016-01-06 |
| Summary: | summary |
Trademark Results [Piccolo Composite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PICCOLO COMPOSITE 85024876 4068081 Live/Registered |
CARBOFIX ORTHOPEDICS LTD. 2010-04-28 |
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