FLOW-NAIL

Rod, Fixation, Intramedullary And Accessories

FLOW-FX, LLC

The following data is part of a premarket notification filed by Flow-fx, Llc with the FDA for Flow-nail.

Pre-market Notification Details

• Device ID: K140601
• 510k Number: K140601
• Device Name: FLOW-NAIL
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: FLOW-FX, LLC 1331 H STREET NW, 12TH FLOOR REGULATORY AFFAIRS DIVISION Washington, DC 20005
• Contact: Michelle Mcdonough
• Correspondent: Michelle Mcdonough; FLOW-FX, LLC 1331 H STREET NW, 12TH FLOOR REGULATORY AFFAIRS DIVISION Washington, DC 20005
• Product Code: HSB
• CFR Regulation Number: 888.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-03-10
• Decision Date: 2014-07-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B267101520	K140601	000
B267101003011150	K140601	000
B267101003011200	K140601	000
B2671010040200	K140601	000
B2671010040220	K140601	000
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B2671010040300	K140601	000
B2671010040320	K140601	000
B2671010040340	K140601	000
B267101003011100	K140601	000
B267101003011050	K140601	000
B267101530	K140601	000
B267101540	K140601	000
B267101610	K140601	000
B267101620	K140601	000
B267101630	K140601	000
B267101003010800	K140601	000
B267101003010850	K140601	000
B267101003010900	K140601	000
B267101003010950	K140601	000
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B2671010040360	K140601	000
B2671010040380	K140601	000
B2671010040700	K140601	000
B2671010040750	K140601	000
B2671010040800	K140601	000
B2671010060000	K140601	000
B2671010060010	K140601	000
B2671010060020	K140601	000
B2671010060030	K140601	000
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B2671010060050	K140601	000
B2671010080000	K140601	000
B2671010040650	K140601	000
B2671010040600	K140601	000
B2671010040400	K140601	000
B2671010040420	K140601	000
B2671010040440	K140601	000
B2671010040460	K140601	000
B2671010040480	K140601	000
B2671010040500	K140601	000
B2671010040520	K140601	000
B2671010040540	K140601	000
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B2671010080010	K140601	000
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B26710172D0	K140601	000
B267101980	K140601	000
B267101990	K140601	000
B267101LS1080R0	K140601	000
B267101LS1085R0	K140601	000
B267101LS1090R0	K140601	000
B267101LS1095R0	K140601	000
B267101LS1100R0	K140601	000
B267101LS1105R0	K140601	000
B267101710	K140601	000
B267101640	K140601	000
B267101080	K140601	000
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B267101600	K140601	000
B267101LS1110R0	K140601	000
B267101LS1115R0	K140601	000
B267101160	K140601	000
B267101170	K140601	000
B267101200	K140601	000
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B267101250	K140601	000
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B267101270	K140601	000
B267101400	K140601	000
B267101150	K140601	000
B267101140	K140601	000
B267101LS1120R0	K140601	000
B267101010	K140601	000
B267101020	K140601	000
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B267101120	K140601	000
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B267C260	K140601	000
B267C261	K140601	000
B267C280	K140601	000
B267C281	K140601	000
B267C300	K140601	000
B267C301	K140601	000
B267C320	K140601	000
B267C441	K140601	000
B267C460	K140601	000
B267C581	K140601	000
B267C600	K140601	000
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B267C650	K140601	000
B267C651	K140601	000
B267C700	K140601	000
B267C701	K140601	000
B267C750	K140601	000
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B267C800	K140601	000
B267C580	K140601	000
B267C561	K140601	000
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B267C480	K140601	000
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B267C500	K140601	000
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B267C540	K140601	000
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B267C560	K140601	000
B267C801	K140601	000
B267C201	K140601	000
B2671010080100	K140601	000
B267101LSCR1090TI1	K140601	000
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B267101LSCR1095TI1	K140601	000
B267101LSCR1100TI0	K140601	000
B267101LSCR1100TI1	K140601	000
B267101LSCR1105TI0	K140601	000
B267101LSCR1105TI1	K140601	000
B267101LSCR1110TI0	K140601	000
B267101LSCR1110TI1	K140601	000
B267101LSCR1115TI0	K140601	000
B267101LSCR1090TI0	K140601	000
B267101LSCR1085TI1	K140601	000
B2671010080110	K140601	000
B2671010090000	K140601	000
B267101060	K140601	000
B267101061	K140601	000
B267101700	K140601	000
B267101CAP1601TI0	K140601	000
B267101CAP1601TI1	K140601	000
B267101LSCR1080TI0	K140601	000
B267101LSCR1080TI1	K140601	000
B267101LSCR1085TI0	K140601	000
B267101LSCR1115TI1	K140601	000
B267101LSCR1120TI0	K140601	000
B267A500	K140601	000
B267A501	K140601	000
B267A600	K140601	000
B267A601	K140601	000
B267A700	K140601	000
B267A701	K140601	000
B267A800	K140601	000
B267A801	K140601	000
B267A900	K140601	000
B267A901	K140601	000
B267A1001	K140601	000
B267A1000	K140601	000
B267101LSCR1120TI1	K140601	000
B267101NAIL125180TI0	K140601	000
B267101NAIL125180TI1	K140601	000
B267101NAIL125220TI0	K140601	000
B267101NAIL125220TI1	K140601	000
B267101NAIL130180TI0	K140601	000
B267101NAIL130180TI1	K140601	000
B267101NAIL130220TI0	K140601	000
B267101NAIL130220TI1	K140601	000
B267101NCAP1601TI0	K140601	000
B267C200	K140601	000