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510(k) Data Aggregation
K Number
K081673Device Name
DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE
Manufacturer
IONICS MEDICAL CORP.
Date Cleared
2008-11-14
(154 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
IONICS MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dyn-ALIF device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device is designed for use with autogenous bone graft to facilitate fusion.
The Dyn-ALIF device is intended for use at either one level or two contiguous levels in the lumbar spine from L2 to S1 for the treatment of degenerative disc disease (DDD) with up to grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had at least six months of non-operative treatment. The device is intended to be used with supplemental internal spinal fixation systems which are cleared by the FDA for use in the lumbar spine.
Device Description
The Dyn-ALIF Anterolateral Intervertebral Body Fusion Device is an implantable device manufactured from titanium alloy which is available in the abutting plate interface dimension of 20mm x 30mm and a vertically expandable height ranging from 11mm anterior /9mm posterior to 15mm anterior/13mm posterior to suit the individual anatomic conditions of the patient. The assembled device consists of five components: two abutting plates with hollow threaded shafts, a central turnbuckle sleeve and two locking set screws. The components can be rigidly locked into a variety of heights, with each construct height measured for the individual case
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K Number
K011181Device Name
ICS MEDICAL CHARTR OAE WITH TYMP
Manufacturer
ICS MEDICAL CORP.
Date Cleared
2001-06-25
(68 days)
Product Code
EWO
Regulation Number
874.1050Why did this record match?
Applicant Name (Manufacturer) :
ICS MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002985Device Name
ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS
Manufacturer
ICS MEDICAL CORP.
Date Cleared
2000-12-13
(79 days)
Product Code
GWJ
Regulation Number
882.1900Why did this record match?
Applicant Name (Manufacturer) :
ICS MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K983667Device Name
IONICS LEVANTE INTERVERTEBRAL PILLAR, EXPANDABLE
Manufacturer
IONICS MEDICAL CORP.
Date Cleared
2000-07-05
(625 days)
Product Code
MQP
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
IONICS MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- The Levante Intervertebral Pillar prosthesis is intended for use in the thoracolumbar spine (i.e., T1 to L5) to replace and to restore the height of a diseased vertebral body resected or excised for the treatment of tumor as well as to concomitantly facilitate anterior decompression of the spinal cord and neural tissues. Two contiguous vertebral bodies are the maximum number of bodies the device is intended to replace. The device is intended to be always implanted with adjunctive fixation.
- To replace a vertebral body for tumor and to replace or restore the height of a vertebral body due to fracture; for example, burst or compression fractures
- To facilitate anterior decompression of the spinal cord and neural structure
- To facilitate the reduction of kyphotic deformities
Device Description
Not Found
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K Number
K991497Device Name
ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM
Manufacturer
ICS MEDICAL CORP.
Date Cleared
1999-07-28
(90 days)
Product Code
GWN
Regulation Number
882.1460Why did this record match?
Applicant Name (Manufacturer) :
ICS MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is used to observe, record and measure eye movements in patients during testing of vestibular function.
Device Description
The CHARTR® ENG/VNG Diagnostic System is a computer based medical device consisting of a Computer utilizing the Pentium III processor, Windows 98 Operating System. Computer Monitor, two Display Monitors for viewing eve movements and utilizes the following accessories: Light Bar, Video Goggles, External Isolation Transformer. Video Distribution Amplifier. Caloric Stimulator. Color Printer, Patient Electrodes, and Interconnection Cables.
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K Number
K972631Device Name
ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER
Manufacturer
ICS MEDICAL CORP.
Date Cleared
1997-09-22
(70 days)
Product Code
GWN, 84G
Regulation Number
882.1460Why did this record match?
Applicant Name (Manufacturer) :
ICS MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is used to record and visually display movements of the eyes including nystagmus.
Device Description
The VEMR™ Eye Movement Recorder is used to observe or record eye movements on a video monitor or video recording tape respectively. This device consists of: patient eye goggles, a video image splitter/power-supply, a video tape cassette recorder (VCR) video monitor console, and a remote control accessory. There is also a built-in microphone in the eye goggles to provide simultaneous voice recording's on a video recording tape. The patient eye goggles are an opaque, facially worn device fitted with tiny video cameras, infrared light emitting diodes (LED's), and a microphone. The diodes illuminate the eyes for video cameras that produce video signals. These signals are processed by the image processor that essentially allows for simultaneous viewing the video images of both eyes on the video screen. The microphone allows for recording of voices to help document events recorded on video tape. The remote control accessory provides remote control of the various functions (e.g. play, record etc.) on the VCR/video monitor console.
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K Number
K960097Device Name
CHARTR EP
Manufacturer
ICS MEDICAL CORP.
Date Cleared
1997-02-21
(407 days)
Product Code
GWJ
Regulation Number
882.1900Why did this record match?
Applicant Name (Manufacturer) :
ICS MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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