Medical Device Manufacturer · US , Planisboro , NJ

Integra LifeSciences Corporation

65 submissions · 65 cleared · Since 2004
65
Total
65
Cleared
0
Denied

Integra LifeSciences Corporation — FDA 510(k) Submissions

Integra LifeSciences Corporation has submitted 65 FDA 510(k) premarket notifications since 2004, of which 65 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Instrument, Ultrasonic Surgical, Shunt, Central Nervous System And Components, Holder, Head, Neurosurgical (skull Clamp), Device, Monitoring, Intracranial Pressure, Shoulder Prosthesis, Reverse Configuration . Use the specialty filter in the sidebar to narrow results.

65 devices
1–25 of 65
CUSA? Clarity Ultrasonic Surgical Aspirator System
K251162 · LFL Instrument, Ultrasonic... · General & Plastic Surgery
Oct 2025 176d
AURORA? Surgiscope? System (ASX15/60); AURORA? Surgiscope? System (ASX15/80)
K250752 · GWG Endoscope, Neurological · Neurology
Apr 2025 28d
CUSA? Clarity Ultrasonic Surgical Aspirator System
K240493 · LFL Instrument, Ultrasonic... · Obstetrics & Gynecology
Jul 2024 142d
CUSA Clarity Ultrasonic Surgical Aspirator System
K230427 · LFL Instrument, Ultrasonic... · General & Plastic Surgery
Jul 2023 144d
CUSA Clarity Ultrasonic Surgical Aspirator System
K221835 · LFL Instrument, Ultrasonic... · General & Plastic Surgery
Aug 2022 60d
CUSA Clarity Ultrasonic Surgical Aspirator System
K221763 · LFL Instrument, Ultrasonic... · General & Plastic Surgery
Jul 2022 28d
INTEGRA Wound Matrix (Macro-Channels)
K210128 · KGN Wound Dressing With... · General & Plastic Surgery
Oct 2021 262d
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
K210016 · HRS Plate, Fixation, Bone · Orthopedic
Jul 2021 204d
Codman Surgical Patties & Strips
K193346 · HBA Neurosurgical Paddie · Neurology
Nov 2020 353d
Cadence Total Ankle System
K201507 · HSN Prosthesis, Ankle,... · Orthopedic
Jun 2020 24d
CUSA Clarity Ultrasonic Surgical Aspirator System
K200774 · LFL Instrument, Ultrasonic... · Neurology
Jun 2020 90d
Integra TITAN Reverse Shoulder System
K190588 · PHX Shoulder Prosthesis,... · Orthopedic
Dec 2019 270d
MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System
K191684 · JXG Shunt, Central Nervous... · Neurology
Oct 2019 109d
CUSA Clarity Ultrasonic Surgical Aspirator System
K190180 · LFL Instrument, Ultrasonic... · General & Plastic Surgery
Apr 2019 59d
CUSA Clarity Ultrasonic Surgical Aspirator System
K182809 · LFL Instrument, Ultrasonic... · General & Plastic Surgery
Dec 2018 65d
Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable
K182801 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Nov 2018 56d
Panta 2 Arthrodesis Nail System
K181639 · HSB Rod, Fixation,... · Orthopedic
Nov 2018 134d
Integra TITAN Reverse Shoulder System
K181999 · PHX Shoulder Prosthesis,... · Orthopedic
Oct 2018 78d
Integra TITAN Reverse Shoulder System
K173717 · PHX Shoulder Prosthesis,... · Orthopedic
Jun 2018 198d
CUSA Excel+ Ultrasonic Surgical Aspirator System
K172595 · LFL Instrument, Ultrasonic... · General & Plastic Surgery
Sep 2017 30d
DuraGen Secure Dural Regeneration Matrix
K163456 · GXQ Dura Substitute · Neurology
Jan 2017 28d
NeuraGen 3D Nerve Guide Matrix
K163457 · JXI Cuff, Nerve · Neurology
Jan 2017 28d
CRW STEREOTACTIC SYSTEM
K160811 · HAW Neurological Stereotaxic... · Neurology
Dec 2016 257d
CUSA Clarity Ultrasonic Surgical Aspirator System
K161882 · LFL Instrument, Ultrasonic... · General & Plastic Surgery
Oct 2016 95d
Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems
K161992 · JXG Shunt, Central Nervous... · Neurology
Sep 2016 65d
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