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
07290109337906	K151010	000
07290109336466	K151010	000
07290109336459	K151010	000
07290109336442	K151010	000
07290109336435	K151010	000
07290109336428	K151010	000
07290109336411	K151010	000
07290109336404	K151010	000
07290109335520	K151010	000
07290109335513	K151010	000
07290109335506	K151010	000
07290109336473	K151010	000
07290109336480	K151010	000
07290109336497	K151010	000
07290109337869	K151010	000
07290109337852	K151010	000
07290109337845	K151010	000
07290109337524	K151010	000
07290109336558	K151010	000
07290109336541	K151010	000
07290109336534	K151010	000
07290109336527	K151010	000
07290109336510	K151010	000
07290109336503	K151010	000
07290109335490	K151010	000
07290109335483	K151010	000
07290110205492	K151010	000
07290110205485	K151010	000
07290110205478	K151010	000
07290110205461	K151010	000
07290110205454	K151010	000
07290110205447	K151010	000
07290110205430	K151010	000
07290117350683	K151010	000
07290117350676	K151010	000
07290117358467	K151010	000
07290110205508	K151010	000
07290110205515	K151010	000
07290110205522	K151010	000
07290109335476	K151010	000
07290109335469	K151010	000
07290109335452	K151010	000
07290109332420	K151010	000
07290110205584	K151010	000
07290110205577	K151010	000
07290110205560	K151010	000
07290110205553	K151010	000
07290110205546	K151010	000
07290110205539	K151010	000
07290117358450	K151010	000
07290109337913	K151010	000
07290110204389	K151010	000
07290109338361	K151010	000
07290109338354	K151010	000
07290109338347	K151010	000
07290109338330	K151010	000
07290109338323	K151010	000
07290109338316	K151010	000
07290109338309	K151010	000
07290109338293	K151010	000
07290109338286	K151010	000
07290109338279	K151010	000
07290109338378	K151010	000
07290109338385	K151010	000
07290109338392	K151010	000
07290110200756	K151010	000
07290109339948	K151010	000
07290109338781	K151010	000
07290109338460	K151010	000
07290109338453	K151010	000
07290109338446	K151010	000
07290109338439	K151010	000
07290109338422	K151010	000
07290109338415	K151010	000
07290109338408	K151010	000
07290109338217	K151010	000
07290109338200	K151010	000
07290109338040	K151010	000
07290109338033	K151010	000
07290109338026	K151010	000
07290109337999	K151010	000
07290109337982	K151010	000
07290109337975	K151010	000
07290109337968	K151010	000
07290109337951	K151010	000
07290109337944	K151010	000
07290109337937	K151010	000
07290109338057	K151010	000
07290109338064	K151010	000
07290109338071	K151010	000
07290109338187	K151010	000
07290109338170	K151010	000
07290109338163	K151010	000
07290109338156	K151010	000
07290109338132	K151010	000
07290109338125	K151010	000
07290109338118	K151010	000
07290109338101	K151010	000
07290109338095	K151010	000
07290109338088	K151010	000
07290109337920	K151010	000