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510(k) Data Aggregation
K Number
K062103Device Name
DARCO FORCE TITANIUM COMPRESSION SCREW
Manufacturer
DARCO INTERNATIONAL, INC.
Date Cleared
2006-10-25
(93 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
DARCO INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DARCO Force Titanium Compression Screw is to be used on indications that are common for currently marketed compression screws. The primary indication for use is the fixation and stabilization of the fractures and non-unions of small bones and small bone arthrodeses including but not limited to intra-articular fractures of the tarsals, metatarsal, carpals and metacarpals, bunionectomies and osteotomies, arthrodesis of small joints (e.g. phalanges).
Device Description
The DARCO Force Compression Screw is a self drilling, self tapping and self counter sinking 3.2mm hex drive cannulated screw with a reverse cutting nib designed into the thread pattern. The cannulated feature allows for the use of a drill guide for precise placement while the smooth shank between the threaded portions of the screw allows the bone surfaces to be compressed to facilitate healing. The screws are made of Ti 6-Al 4-V biocompatible titanium alloy and coated with an anodized finish.
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K Number
K061808Device Name
DARCO LOCKING BONE PLATE SYSTEM
Manufacturer
DARCO INTERNATIONAL, INC.
Date Cleared
2006-08-17
(51 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
DARCO INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DARCO Locking Bone Plate System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system may be used in both adult and pediatric patients.
Device Description
The DARCO Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The plates vary essentially through different curvatures, material strengths, lengths, number of plate holes and through different grades or bridge widths.
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