Medical Device Manufacturer · US , Somerville , NJ

Integra Lifesciences Corp.

29 submissions · 29 cleared · Since 1999
29
Total
29
Cleared
0
Denied

Integra Lifesciences Corp. — FDA 510(k) Submissions

Integra Lifesciences Corp. has submitted 29 FDA 510(k) premarket notifications since 1999, of which 29 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Wound Dressing With Animal-derived Material(s), Shunt, Central Nervous System And Components, Dura Substitute, Device, Monitoring, Intracranial Pressure, Holder, Head, Neurosurgical (skull Clamp) . Use the specialty filter in the sidebar to narrow results.

29 devices
1–25 of 29
Codman Disposable Perforators
K183581 · HBF Drills, Burrs, Trephines... · Neurology
Jan 2019 30d
CereLink ICP Monitor, CereLink ICP Extension Cable
K183406 · GWM Device, Monitoring,... · Neurology
Jan 2019 32d
CodMan Certas Plus Programmable Valve
K182265 · JXG Shunt, Central Nervous... · Neurology
Nov 2018 91d
Codman Certas Plus Electronic Tool Kit
K181902 · JXG Shunt, Central Nervous... · Neurology
Oct 2018 101d
CUSA Excel+
K150682 · LFL Instrument, Ultrasonic... · General & Plastic Surgery
Dec 2015 276d
Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs
K150428 · HAE Rongeur, Manual · Neurology
Apr 2015 56d
INTEGRA LICOX PTO2 MONITOR
K131184 · GWM Device, Monitoring,... · Neurology
Aug 2013 127d
JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS
K092227 · HAE Rongeur, Manual · Neurology
Feb 2010 209d
OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM
K092395 · JXG Shunt, Central Nervous... · Neurology
Nov 2009 106d
INTEGRA MESHED BILAYER WOUND MATRIX
K081635 · KGN Wound Dressing With... · General & Plastic Surgery
Dec 2008 176d
MAYFIELD MR/X-RAY SKULL CLAMP
K081401 · HBL Holder, Head,... · Neurology
Oct 2008 142d
INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301
K072113 · KGN Wound Dressing With... · General & Plastic Surgery
Oct 2007 70d
DURAGEN XS DURAL REGENERATION MATRIX
K072207 · GXQ Dura Substitute · Neurology
Aug 2007 15d
INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS
K063124 · MQV Filler, Bone Void,... · Orthopedic
Jan 2007 98d
LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT
K053244 · GWM Device, Monitoring,... · Neurology
May 2006 170d
MAYFIELD INFINITY SKULL CLAMP
K051440 · HBL Holder, Head,... · Neurology
Sep 2005 110d
MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104
K050319 · HBL Holder, Head,... · Neurology
Mar 2005 50d
INTEGRA BONE FIXATION SYSTEM
K050492 · HRS Plate, Fixation, Bone · Orthopedic
Mar 2005 14d
DURAGEN II DURAL REGENERATION MATRIX
K043427 · GXQ Dura Substitute · Neurology
Jan 2005 30d
NEURA WRAP NERVE PROTECTOR
K041620 · JXI Cuff, Nerve · Neurology
Jul 2004 30d
DURAGEN PLUS DURAL GRAFT MATRIX
K032693 · GXQ Dura Substitute · Neurology
Sep 2003 28d
HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N
K030289 · JXG Shunt, Central Nervous... · Neurology
Feb 2003 29d
AVAGEN WOUND DRESSING
K022127 · KGN Wound Dressing With... · General & Plastic Surgery
Sep 2002 71d
BILAYER MATRIX WOUND DRESSING
K021792 · KGN Wound Dressing With... · General & Plastic Surgery
Aug 2002 75d
BIOPATCH ANTIMICROBIAL DRESSING
K003229 · SEL Securement Wound Dressing... · General & Plastic Surgery
Oct 2001 381d
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