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Found 6 results
510(k) Data Aggregation
K Number
K072740Device Name
MONDEAL EXTREMITY BONE FIXATION SYSTEM
Manufacturer
MONDEAL MEDICAL SYSTEMS GMBH
Date Cleared
2007-11-19
(53 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
MONDEAL MEDICAL SYSTEMS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K071797Device Name
MONDEAL HAND CONTOUR SYSTEM
Manufacturer
MONDEAL MEDICAL SYSTEMS GMBH
Date Cleared
2007-09-17
(77 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
MONDEAL MEDICAL SYSTEMS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mondeal® HAND CONTOUR System is intended to be used for the internal fixation of small bones including the hand and the foot.
Device Description
The Mondeal® Hand Contour System consists of titanium plates with shapes and sizes designed for internal fixation of small bones including the hand and foot, and screws of varying lengths from 4 to 23 mm and 1.2 , 1.7, and 2.3 mm in diameter, supplied nonsterile packaged together in either tempered plastic or stainless steel trays suitable for recommended steam sterilisation, and also individually for single implantable use. The plates include straight, "T" shaped and condylar configurations. Manual reusable surgical instruments are supplied to facilitate implantation
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K Number
K071798Device Name
MONDEAL DISTAL RADIUS SYSTEM
Manufacturer
MONDEAL MEDICAL SYSTEMS GMBH
Date Cleared
2007-09-17
(77 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
MONDEAL MEDICAL SYSTEMS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mondeal® DISTAL RADIUS System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect.
Device Description
The Mondeal® Distal Radius System consists of titanium volar and dorsal plates with shapes and sizes designed for internal fixation of distal radius fractures and osteotomies, and screws of varying lengths from 8 to 38 mm and 2.7 or 3.0 mm in diameter, supplied non-sterile packaged together in either tempered plastic or stainless steel trays suitable for recommended steam sterilisation, and also individually for single implantable use. The plates include dorsal and volar "T" shaped right and configurations. Manual reusable surgical instruments may be supplied to facilitate implantation.
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K Number
K062436Device Name
SIS SINUS IMPLANT STABILIZER
Manufacturer
MONDEAL MEDICAL SYSTEMS GMBH
Date Cleared
2007-07-30
(343 days)
Product Code
JEY
Regulation Number
872.4760Why did this record match?
Applicant Name (Manufacturer) :
MONDEAL MEDICAL SYSTEMS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SIS Sinus Implant Stabilizer is intended to provide a fixed anchorage point to stabilize dental implants in the sinus region, enabling sinus augmentation and implantation to be carried out in one session.
Device Description
The SIS Sinus Implant Stabilizer consists of a titanium plate provided with 3 large perforations for screw fixation of implants for premolars and first molars. It may be additionally secured in place with titanium microscrews and is provided in two sizes for use with different implant systems.
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K Number
K050257Device Name
LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE)
Manufacturer
MONDEAL MEDICAL SYSTEMS GMBH
Date Cleared
2005-02-07
(4 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
MONDEAL MEDICAL SYSTEMS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lin/Liou Orthodontic Mini Anchor System (LOMAS) (Sterile) is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.
Device Description
Not Found
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K Number
K042345Device Name
LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS)
Manufacturer
MONDEAL MEDICAL SYSTEMS GMBH
Date Cleared
2005-01-13
(136 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
MONDEAL MEDICAL SYSTEMS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lin/Liou Orthodontic Mini Anchor System (LOMAS) is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only
Device Description
Lin/Liou Orthodontic Mini Anchor System (LOMAS)
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