FDA 510(k) Applications Submitted by Integra Lifesciences Corporation

FDA 510(k) Number Submission Date Device Name Applicant
K190180 02/01/2019 CUSA Clarity Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation
K230427 02/17/2023 CUSA Clarity Ultrasonic Surgical Aspirator System Integra Lifesciences Corporation
K200774 03/25/2020 CUSA Clarity Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation
K221763 06/17/2022 CUSA Clarity Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation
K221835 06/23/2022 CUSA Clarity Ultrasonic Surgical Aspirator System Integra Lifesciences Corporation
K172595 08/29/2017 CUSA Excel+ Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation
K193346 12/03/2019 Codman Surgical Patties & Strips Integra LifeSciences Corporation
K210016 01/04/2021 Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal Integra Lifesciences Corporation
K190588 03/07/2019 Integra TITAN Reverse Shoulder System Integra LifeSciences Corporation
K181639 06/21/2018 Panta 2 Arthrodesis Nail System Integra Lifesciences Corporation
K181999 07/26/2018 Integra TITAN Reverse Shoulder System Integra Lifesciences Corporation
K142238 08/13/2014 MAYFIELD Skull Clamp INTEGRA LIFESCIENCES CORPORATION
K201507 06/05/2020 Cadence Total Ankle System Integra Lifesciences Corporation
K042825 10/12/2004 ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM INTEGRA LIFESCIENCES CORPORATION
K062599 09/01/2006 MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS INTEGRA LIFESCIENCES CORPORATION
K072929 10/16/2007 LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030 INTEGRA LIFESCIENCES CORPORATION
K102802 09/27/2010 INTEGRA ELECTRODE TUNNELING NEEDLE INTEGRA LIFESCIENCES CORPORATION
K062353 08/11/2006 MOZAIK BONE REGENERATION MATRIX - PUTTY INTEGRA LIFESCIENCES CORPORATION
K053655 12/30/2005 TENDON WRAP TENDON PROTECTOR INTEGRA LIFESCIENCES CORPORATION
K101381 05/17/2010 HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS INTEGRA LIFESCIENCES CORPORATION
K102875 10/01/2010 CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C INTEGRA LIFESCIENCES CORPORATION
K093968 12/23/2009 OSV II LOW FLOW LOW PRO VALVE INTEGRA LIFESCIENCES CORPORATION
K071458 05/25/2007 MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS INTEGRA LIFESCIENCES CORPORATION
K053045 10/28/2005 MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 INTEGRA LIFESCIENCES CORPORATION
K040860 04/02/2004 INTEGRA BONE FIXATION SYSTEM INTEGRA LIFESCIENCES CORPORATION
K133754 12/09/2013 INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER INTEGRA LIFESCIENCES CORPORATION
K163457 12/09/2016 NeuraGen 3D Nerve Guide Matrix Integra LifeSciences Corporation
K090506 02/25/2009 MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114 INTEGRA LIFESCIENCES CORPORATION
K072208 08/08/2007 MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS INTEGRA LIFESCIENCES CORPORATION
K130389 02/15/2013 MAYFIELD INFINITY XR2 SKULL CLAMP INTEGRA LIFESCIENCES CORPORATION
K140722 03/21/2014 INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS INTEGRA LIFESCIENCES CORPORATION
K141668 06/23/2014 CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM INTEGRA LIFESCIENCES CORPORATION
K161992 07/19/2016 Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems INTEGRA LIFESCIENCES CORPORATION
K152897 10/01/2015 Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory INTEGRA LIFESCIENCES CORPORATION
K182801 10/02/2018 Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable Integra LifeSciences Corporation
K071505 06/01/2007 MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM INTEGRA LIFESCIENCES CORPORATION
K061640 06/12/2006 INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM INTEGRA LIFESCIENCES CORPORATION
K142414 08/28/2014 Miltex N-Tralig Intraligamentary Syringe INTEGRA LIFESCIENCES CORPORATION
K173717 12/05/2017 Integra TITAN Reverse Shoulder System Integra LifeSciences Corporation
K120633 03/01/2012 MAYFIELD SKULL CLAMP INTEGRA LIFESCIENCES CORPORATION
K182809 10/03/2018 CUSA Clarity Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation
K040235 02/02/2004 LICOX PMO BRAIN MONITORING SYSTEM INTEGRA LIFESCIENCES CORPORATION
K191684 06/24/2019 MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System Integra Lifesciences Corporation
K091302 05/04/2009 INTEGRA MOZAIK AND OS MOLDABLE MORSELS INTEGRA LIFESCIENCES CORPORATION
K092388 08/05/2009 DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO INTEGRA LIFESCIENCES CORPORATION
K161882 07/11/2016 CUSA Clarity Ultrasonic Surgical Aspirator System INTEGRA LIFESCIENCES CORPORATION
K134047 12/31/2013 JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS INTEGRA LIFESCIENCES CORPORATION
K210128 01/19/2021 INTEGRA Wound Matrix (Macro-Channels) Integra LifeSciences Corporation
K120012 01/03/2012 INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS INTEGRA LIFESCIENCES CORPORATION
K103726 12/22/2010 JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS INTEGRA LIFESCIENCES CORPORATION
K131446 05/20/2013 INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES INTEGRA LIFESCIENCES CORPORATION
K093163 10/06/2009 INTEGRA TOTAL WRIST FUSION SYSTEM INTEGRA LIFESCIENCES CORPORATION
K130557 03/04/2013 NEURAGEN 3D INTEGRA LIFESCIENCES CORPORATION
K123000 09/27/2012 INTEGRA TOTAL FOOT SYSTEMS INTEGRA LIFESCIENCES CORPORATION
K113104 10/20/2011 INTEGRA WOUND MATRIX (THIN) INTEGRA LIFESCIENCES CORPORATION
K160811 03/24/2016 CRW STEREOTACTIC SYSTEM INTEGRA LIFESCIENCES CORPORATION
K141674 06/23/2014 CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM INTEGRA LIFESCIENCES CORPORATION
K153041 10/19/2015 Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling INTEGRA LIFESCIENCES CORPORATION
K161189 04/27/2016 Integra TITAN Reverse Shoulder System INTEGRA LIFESCIENCES CORPORATION
K163456 12/09/2016 DuraGen Secure Dural Regeneration Matrix INTEGRA LIFESCIENCES CORPORATION


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