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Integra LifeSciences Corporation

FDA 510(k) & PMA Approved Devices — 32 products

Total Devices32
Categories15
Latest Approval2025-10-08
TypeNumberDevice NameCodeDate
510(k) K251162 CUSA® Clarity Ultrasonic Surgical Aspirator System LFL 2025-10-08 View
510(k) K250752 AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) GWG 2025-04-09 View
510(k) K240493 CUSA® Clarity Ultrasonic Surgical Aspirator System LFL 2024-07-11 View
510(k) K230427 CUSA Clarity Ultrasonic Surgical Aspirator System LFL 2023-07-11 View
510(k) K221835 CUSA Clarity Ultrasonic Surgical Aspirator System LFL 2022-08-22 View
510(k) K221763 CUSA Clarity Ultrasonic Surgical Aspirator System LFL 2022-07-15 View
510(k) K210128 INTEGRA Wound Matrix (Macro-Channels) KGN 2021-10-08 View
510(k) K210016 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 HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System HRS 2021-07-27 View
510(k) K193346 Codman Surgical Patties & Strips HBA 2020-11-20 View
510(k) K201507 Cadence Total Ankle System HSN 2020-06-29 View
510(k) K200774 CUSA Clarity Ultrasonic Surgical Aspirator System LFL 2020-06-23 View
510(k) K190588 Integra TITAN Reverse Shoulder System PHX 2019-12-02 View
510(k) K191684 MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System JXG 2019-10-11 View
510(k) K190180 CUSA Clarity Ultrasonic Surgical Aspirator System LFL 2019-04-01 View
510(k) K182809 CUSA Clarity Ultrasonic Surgical Aspirator System LFL 2018-12-07 View
510(k) K182801 Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable GEI 2018-11-27 View
510(k) K181639 Panta 2 Arthrodesis Nail System HSB 2018-11-02 View
510(k) K181999 Integra TITAN Reverse Shoulder System PHX 2018-10-12 View
510(k) K173717 Integra TITAN Reverse Shoulder System PHX 2018-06-21 View
510(k) K172595 CUSA Excel+ Ultrasonic Surgical Aspirator System LFL 2017-09-28 View
510(k) K163456 DuraGen Secure Dural Regeneration Matrix GXQ 2017-01-06 View
510(k) K163457 NeuraGen 3D Nerve Guide Matrix JXI 2017-01-06 View
PMA P810006 Agent, absorbable hemostatic, collagen based LMF 2016-12-07 View
PMA P850010 Agent, absorbable hemostatic, collagen based LMF 2016-12-07 View
510(k) K160811 CRW STEREOTACTIC SYSTEM HAW 2016-12-06 View
510(k) K161882 CUSA Clarity Ultrasonic Surgical Aspirator System LFL 2016-10-14 View
510(k) K161992 Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems JXG 2016-09-22 View
510(k) K161189 Integra TITAN Reverse Shoulder System PHX 2016-08-25 View
PMA P040034 Sealant, dural NQR 2016-07-15 View
PMA P080013 Sealant, dural NQR 2016-07-15 View
510(k) K153041 Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling JXG 2016-03-14 View
510(k) K152897 Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory JXG 2016-03-04 View
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