Medical Device Manufacturer · US , Planisboro , NJ

Integra LifeSciences Corporation - FDA 510(k) Cleared Devices

65 submissions · 65 cleared · Since 2004
65
Total
65
Cleared
0
Denied
65 devices
51-65 of 65
Cleared Dec 15, 2009
INTEGRA TOTAL WRIST FUSION SYSTEM
K093163 · HRS
Orthopedic · 70d
Cleared Dec 04, 2009
INTEGRA MOZAIK AND OS MOLDABLE MORSELS
K091302 · MQV
Orthopedic · 214d
Cleared Apr 20, 2009
MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114
K090506 · HBL
Neurology · 54d
Cleared Dec 07, 2007
LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS...
K072929 · JXG
Neurology · 52d
Cleared Sep 07, 2007
MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS
K072208 · HBL
Neurology · 30d
Cleared Aug 06, 2007
MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE...
K071505 · GWM
Neurology · 66d
Cleared Jun 13, 2007
MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS
K071458 · HBL
Neurology · 19d
Cleared Dec 20, 2006
MOZAIK BONE REGENERATION MATRIX - PUTTY
K062353 · MQV
Orthopedic · 131d
Cleared Sep 27, 2006
MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS
K062599 · JXG
Neurology · 26d
Cleared Jul 27, 2006
INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM
K061640 · GWM
Neurology · 45d
Cleared Feb 03, 2006
TENDON WRAP TENDON PROTECTOR
K053655 · FTM
General & Plastic Surgery · 35d
Cleared Nov 21, 2005
MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
K053045 · HBL
Neurology · 24d
Cleared Dec 21, 2004
ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM
K042825 · JXG
Neurology · 70d
Cleared Jun 17, 2004
INTEGRA BONE FIXATION SYSTEM
K040860 · HRS
Orthopedic · 76d
Cleared Apr 20, 2004
LICOX PMO BRAIN MONITORING SYSTEM
K040235 · GWM
Neurology · 78d
Filters