FDA 510(k) Applications Submitted by BONNIE SMITH

FDA 510(k) Number Submission Date Device Name Applicant
K030390 02/05/2003 SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE SYNTHES (USA)
K010766 03/14/2001 SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE SYNTHES (USA)
K031654 05/28/2003 SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED) SYNTHES (USA)
K031725 06/03/2003 SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM SYNTHES (USA)
K031724 06/03/2003 SYNTHES SMALL COBINATION CLAMP-MR SAFE SYNTHES (USA)
K033065 09/29/2003 SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES SYNTHES (USA)
K033411 10/27/2003 SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS SYNTHES (USA)
K033556 11/12/2003 SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM SYNTHES (USA)
K033618 11/18/2003 SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM SYNTHES (USA)
K030069 01/08/2003 SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM SYNTHES (USA)
K000089 01/12/2000 SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS SYNTHES (USA)
K010344 02/05/2001 ADJUSTABLE LARGE FIXATOR SYSTEM SYNTHES (USA)
K000560 02/18/2000 SYNTHES (USA) RESORBABLE TACK SYSTEM SYNTHES (USA)
K000972 03/27/2000 SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS SYNTHES (USA)
K011034 04/05/2001 SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM SYNTHES (USA)
K001311 04/25/2000 SYNTHES (USA) ORIBITAL MESH PLATES SYNTHES (USA)
K021382 05/02/2002 SYNTHES (USA) AUTOMATED TACK DRIVER SYNTHES (USA)
K031428 05/06/2003 SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE SYNTHES (USA)
K021556 05/13/2002 SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW SYNTHES (USA)
K031573 05/20/2003 SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE SYNTHES (USA)
K031677 05/30/2003 SYNTHES (USA) CALVICLE HOOK PLATE SYNTHES (USA)
K031807 06/11/2003 SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS SYNTHES (USA)
K021932 06/12/2002 SYNTHES 6.5 MM CANNULATED SCREW SYNTHES (USA)
K021928 06/12/2002 SYNTHES (USA) RESORBABLE FIXATION SYSTEM SYNTHES (USA)
K011857 06/14/2001 SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM SYNTHES (USA)
K031973 06/26/2003 SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE SYNTHES (USA)
K061891 07/03/2006 SYNEX II SYNTHES SPINE CO.LP
K062083 07/21/2006 SYNFIX -LR SYNTHES SPINE CO.LP
K002361 08/03/2000 SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM SYNTHES (USA)
K002362 08/03/2000 SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS) SYNTHES (USA)
K002605 08/22/2000 4.0/2.5 MM SELF-DRILLING SCHANZ SCREW SYNTHES (USA)
K002710 08/31/2000 MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION) SYNTHES (USA)
K062933 09/28/2006 SYNTHES ORACLE SPACER SYNTHES SPINE CO.LP
K013527 10/23/2001 MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM SYNTHES (USA)


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