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: K151010
• 510k Number: K151010
• Device Name: Piccolo Composite 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: 2015-04-15
• Decision Date: 2015-07-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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