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510(k) Data Aggregation
K Number
K990816Device Name
AVCORE SYSTEM
Manufacturer
MODULAR CUTTING SYSTEMS, INC.
Date Cleared
1999-09-24
(197 days)
Product Code
HWE
Regulation Number
878.4820Why did this record match?
Applicant Name (Manufacturer) :
MODULAR CUTTING SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AV Core System is a system of cannulated trephines and drills used to obtain and insert a contoured bone graft into a matched hole in the femoral head. The use of the system is indicated for patients suffering from Avascular necrosis, in which the head does not suffer from collapse or degenerative changes.
Device Description
The AvCore System comprises of a series of trephines and purchased canulated drill bits of matched size, used to obtain a appropriate sized and contoured bone graft in the treatment of avascular necrosis of the femoral head. The device is classified under the nomenclature of drills, burs, Trephines & accessories ( compound, powered). The product code is 84HBF and regulation number 882:4305 and is a Class II device.
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K Number
K991037Device Name
EUCLID REDUCTION AND GUIDANCE SYSTEM
Manufacturer
MODULAR CUTTING SYSTEMS, INC.
Date Cleared
1999-06-23
(86 days)
Product Code
JDS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
MODULAR CUTTING SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Euclid Reduction and Positioning System is an adjunct to any intramedullary rod to aid in both the reduction of a femur fracture and to aid in the targeting of the distal screws placed across the rod. It is considered to aid in any type femur fracture for which intramedullary rod fixation is indicated.
Device Description
Not Found
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