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510(k) Data Aggregation
K Number
K050754Device Name
PRECIMED CANNULATED SCREW SYSTEM
Manufacturer
PRECIMED, INC.
Date Cleared
2005-05-18
(56 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
PRECIMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Precimed Cannulated Screw System is indicated for use in the treatment of bone fractures, such as fractures of the tarsals and metatarsals, and for metatarsal and phalangeal osteotomies and arthrodeses.
Device Description
The Precimed Cannulated Screw System is a Cannulated Screw System used for the fixation of bone fractures and for bone reconstructions. It consists of multiple sizes of cannulated screws in varying diameters and lengths. Materials: The devices are manufactured from 316 LVM stainless steel per ASTM and ISO standards. Function: The system functions to provide immediate stability and temporary fixation during the natural healing process following fractures.
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K Number
K023851Device Name
PRECIMED HIP SCREW SYSTEM
Manufacturer
PRECIMED, INC.
Date Cleared
2003-01-28
(70 days)
Product Code
KTT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
PRECIMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Precimed Hip Screw System is indicated for use in the treatment of dis-placed sub-capital fractures, subtrochanteric and intertrochanteric fractures, arthrodesis, moderately displaced femoral capital epiphysis, varus or valgus osteotomies of the hip, medial displacement osteotomies, supracondylar and distal femoral fractures.
Device Description
The Precimed Hip Screw System is a compression fixation system used for the treatment of femoral neck and distal femoral fractures. It consists of compression plates, lag screws, compression screws, bone screws and angled blade plates.
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