FDA 510(k) Applications Submitted by Lisa M Boyle

FDA 510(k) Number Submission Date Device Name Applicant
K100147 01/19/2010 S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM AESCULAP IMPLANT SYSTEM, INC.
K060152 01/20/2006 MODIFICATION TO S4 SPINAL SYSTEM AESCULAP, INC.
K100243 01/27/2010 QUINTEX CERVICAL PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, LLC
K110864 03/29/2011 BIOSPINE VBR SYSTEM AESCULAP IMPLANT SYSTEMS, LLC
K070981 04/06/2007 SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (PLASMAPORE) AESCULAP IMPLANT SYSTEMS, INC.
K080992 04/07/2008 AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, INC.
K081031 04/11/2008 ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE AESCULAP, INC.
K061424 05/23/2006 CELSITE/ CELSITE CONCEPT, ACCESS PORTS AESCULAP, INC.
K031761 06/06/2003 SYNTHES (USA) NEW/STERIAL ORBITAL PLATES SYNTHES (USA)
K041533 06/08/2004 SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS SYNTHES (USA)
K121801 06/19/2012 QUINTEX CERVICAL PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, LLC
K172032 07/05/2017 Modulift Vertebral Body Replacement (VBR) System Aesculap Implants Systems, Inc.
K221947 07/05/2022 Tyber Medical Staple Fixation System (various) Tyber Medical, LLC.
K151938 07/14/2015 S4 Cervical Spinal and Occiput Systems AESCULAP IMPLANT SYSTEMS, LLC
K222465 08/15/2022 Tyber Medical Anatomical Plating System Tyber Medical, LLC
K052390 08/31/2005 SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION SYNTHES (USA)
K172850 09/20/2017 SterilContainer with PrimeLine Pro Lid Aesculap, Inc.
K052683 09/28/2005 SYNTHES (USA) STERNAL FIXATION SYSTEM SYNTHES (USA)
K083004 10/08/2008 MILI (MINIMALLY INVASIVE LUMBAR IMPLANT) SYSTEM AESCULAP IMPLANT SYSTEMS, INC.
K053199 11/16/2005 SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT SYNTHES (USA)
K050041 01/07/2005 SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM SYNTHES (USA)
K040083 01/15/2004 SYNTHES EXTERNAL MIDFACE DISTRACTOR SYNTHES (USA)
K030310 01/30/2003 SYNTHES STAINLESS STEEL MODULAR HAND SYSTEM SYNTHES (USA)
K040272 02/05/2004 SYNTHES (USA) CRANIOFACIAL PLATES SYNTHES (USA)
K130291 02/06/2013 S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEM, INC.
K090354 02/11/2009 LAMINOPLASTY PLATING SYSTEM AESCULAP IMPLANT SYSTEM, INC.
K090375 02/17/2009 ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210 AESCULAP IMPLANT SYSTEM, INC.
K030597 02/25/2003 SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES SYNTHES (USA)
K100623 03/04/2010 AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS
K040588 03/05/2004 SYNTHES (USA) 2.4 MM LCP WRIST PLATE SYNTHES (USA)
K090657 03/12/2009 MODIFICATION TO: S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS
K110695 03/14/2011 BIPOLAR HF DEVICE AESCULAP, INC.
K080753 03/17/2008 AESCULAP ENDOSCOPIC CLIP SYTEM AESCULAP, INC.
K030858 03/18/2003 SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS SYNTHES (USA)
K100802 03/22/2010 AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS, INC.
K040765 03/25/2004 SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS SYNTHES (USA)
K040777 03/26/2004 LCP RADIAL HEAD PLATING SYSTEM SYNTHES (USA)
K130887 03/29/2013 S4C NAVIGATION INSTRUMENTS AESCULAP IMPLANT SYSTEM, INC.
K031178 04/14/2003 SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES SYNTHES (USA)
K111122 04/21/2011 AESCULAP SIBD XP SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS, INC.
K081293 05/07/2008 UNIVATION UNICONDYLAR KNEE SYSTEM AESCULAP IMPLANT SYSTEMS, INC.
K031508 05/14/2003 SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM SYNTHES (USA)
K031555 05/19/2003 SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM SYNTHES (USA)
K041333 05/19/2004 SYNTHES (USA) TITANIUM WIRE SYNTHES (USA)
K091692 06/10/2009 AESCULAP PEEK CRANIOFIX AESCULAP, INC.
K041611 06/15/2004 SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP SYNTHES (USA)
K061699 06/16/2006 EXCIA AESCULAP, INC.
K061704 06/16/2006 OPTILENE MESH AESCULAP, INC.
K032032 07/01/2003 SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES SYNTHES (USA)
K041887 07/12/2004 SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS SYNTHES (USA)
K041911 07/15/2004 SYNTHES (USA) LCP CURVED PLATES SYNTHES (USA)
K062012 07/17/2006 S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM AESCULAP, INC.
K032269 07/23/2003 SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES SYNTHES (USA)
K132421 08/05/2013 AESCULAP PEEK XP SPINAL IMPLANT SYSTEM AESCULAP IMPLANT SYSTEMS, INC.
K142150 08/05/2014 AIS MODULIFT VBR SYSTEM AESCULAP IMPLANT SYSTEM, INC.
K042135 08/09/2004 SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE EXTENSION) SYNTHES (USA)
K062327 08/10/2006 MODIFICATION TO S4 SPINAL SYSTEM AESCULAP, INC.
K062406 08/17/2006 AESCULAP NEURO PATTIES AESCULAP, INC.
K032559 08/19/2003 SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS SYNTHES (USA)
K042356 08/31/2004 SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS SYNTHES (USA)
K042377 09/01/2004 SYNTHES LOW PROFILE RECONSTRUCTION PLATES SYNTHES (USA)
K112551 09/01/2011 S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEM, INC.
K052483 09/09/2005 SYNTHES (USA) SPHERICAL WASHERS SYNTHES (USA)
K142707 09/22/2014 AIS Odontoid Fracture Fixation System AESCULAP IMPLANT SYSTEM, INC.
K033071 09/29/2003 SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM SYNTHES (USA)
K033121 09/30/2003 1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES SYNTHES (USA)
K033160 09/30/2003 SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES SYNTHES (USA)
K042987 10/29/2004 MODIFICATION TO SYNTHES CRANIAL PLATES SYNTHES (USA)
K042986 10/29/2004 MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM SYNTHES (USA)
K123352 10/31/2012 S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS, INC.
K053105 11/04/2005 SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP SYNTHES (USA)
K103284 11/05/2010 LAMINOPLASY PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, INC.
K023802 11/14/2002 SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM SYNTHES (USA)
K043185 11/17/2004 SYNTHES 3.5MM CORTEX SCREWS SYNTHES (USA)
K023879 11/21/2002 SMALL TITANIUM WRIST FUSION PLATE SYNTHES (USA)
K023941 11/26/2002 SYNTHES TOMOFIX OSTEOTOMY SYSTEM SYNTHES (USA)
K043310 12/01/2004 SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM SYNTHES (USA)
K033805 12/08/2003 SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES SYNTHES (USA)
K033816 12/09/2003 SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM SYNTHES (USA)
K033868 12/12/2003 SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS SYNTHES (USA)
K133802 12/13/2013 AIS MODULIFT VBR SYSTEM AESCULAP IMPLANT SYSTEM, INC.
K083772 12/18/2008 COLUMBUS REVISION KNEE SYSTEM AESCULAP IMPLANT SYSTEM, INC.
K153629 12/18/2015 ArcadiusXP C Spinal System Aesculap Implant Systems, Inc.
K123909 12/19/2012 AESCULAP CESPACE XP AESCULAP IMPLANT SYSTEM, INC.
K123939 12/20/2012 S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS, INC.
K033975 12/23/2003 SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS SYNTHES (USA)
K033995 12/24/2003 3.5 MM LCP DISTAL HUMERUS SYSTEM SYNTHES (USA)
K151056 04/20/2015 Aesculap T-Space PEEK and XP Spinal System AESCULAP IMPLANT SYSTEMS, LLC


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