FDA 510(k) Applications Submitted by Patrick Hughes

FDA 510(k) Number Submission Date Device Name Applicant
K140063 01/10/2014 EQUINOXE EXTRA SHORT HUMERAL HEAD EXACTECH, INC.
K150066 01/13/2015 Exactech Alteon Monobloc Revision Stem EXACTECH, INC.
K170240 01/26/2017 Truliant Femoral Components Exactech Inc
K140302 02/06/2014 OPTETRAK LOGIC POROUS FEMORAL COMPONENTS EXACTECH, INC.
K130434 02/21/2013 OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC EXACTECH, INC.
K160484 02/22/2016 Optetrak Advanced Patella EXACTECH INC
K110547 02/25/2011 OPTERTRAK LOGIC PSC TIBIAL INSERT EXACTECH SARASOTA
K230572 03/01/2023 AETOS Shoulder System Smith & Nephew, Inc.
K140645 03/13/2014 GIBRALT ROD-TO-ROD CROSS CONNECTORS EXACTECH SARASOTA
K150890 04/02/2015 Exactech Optetrak Logic CC EXACTECH, INC.
K171045 04/07/2017 Exactech« TruliantÖ Line Extensions Exactech, Inc.
K121307 05/01/2012 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ EXACTECH, INC.
K111400 05/19/2011 OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT EXACTECH, INC.
K131575 05/31/2013 EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT EXACTECH, INC.
K181794 07/05/2018 Truliant Porous Femoral Components Exactech, Inc.
K132161 07/12/2013 OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS EXACTECH, INC.
K101981 07/14/2010 OPTETRAK LOGIC COMBINATION TIBIAL TRAY EXACTECH, INC.
K152170 08/04/2015 Exactech Optetrak Logic Enhanced Assembly EXACTECH, INC.
K132582 08/16/2013 EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM EXACTECH, INC.
K182502 09/12/2018 Alteon Acetabular Cup System Exactech, Inc
K093360 10/28/2009 OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T EXACTECH, INC.
K123342 10/31/2012 OPTETRAK LOGIC CRC TIBIAL INSERT EXACTECH, INC.
K113309 11/08/2011 EXACTECH EQUINOXE CAGE GLENOIDS EXACTECH, INC.
K123607 11/21/2012 OCTANE ELEVATE SPINAL IMPLANT SYSTEM EXACTECH, INC.
K103419 11/22/2010 EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM EXACTECH, INC.
K123687 12/03/2012 OPTETRAK LOGIC POROUS FEMORAL COMPONENT EXACTECH, INC.
K103655 12/15/2010 OCTANE-C INTERBODY FUSION DEVICE SYSTEM EXACTECH, INC.
K153595 12/16/2015 Optetrak Logic Metaphyseal Cones EXACTECH INC
K153776 12/31/2015 Optetrak One Logic Femoral Components Exactech Inc


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact