Piccolo Composite® Plate System
Plate, Fixation, Bone
CarboFix Orthopedics Ltd.
The following data is part of a premarket notification filed by Carbofix Orthopedics Ltd. with the FDA for Piccolo Composite® Plate System.
Pre-market Notification Details
| Device ID | K182015 |
| 510k Number | K182015 |
| Device Name: | Piccolo Composite® Plate System |
| Classification | Plate, Fixation, Bone |
| Applicant | CarboFix Orthopedics Ltd. 11 Ha'hoshlim St. Herzeliya, IL 4672411 |
| Contact | Yael Rubin |
| Correspondent | Yael Rubin CarboFix Orthopedics Ltd. 11 Ha'hoshlim St. Herzeliya, IL 4672411 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-27 |
| Decision Date | 2018-10-11 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110205119 | K182015 | 000 |
| 07290110205102 | K182015 | 000 |
| 07290110205096 | K182015 | 000 |
| 07290110205072 | K182015 | 000 |
| 07290110205065 | K182015 | 000 |
| 07290110205058 | K182015 | 000 |
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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