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: K120409
• 510k Number: K120409
• Device Name: PICCOLO COMPOSITE PLATE SYSTEM
• Classification: Plate, Fixation, Bone
• 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: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-02-09
• Decision Date: 2012-11-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07290109334653	K120409	000
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