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510(k) Data Aggregation
K Number
K112675Device Name
ARROW-LOK DIGITAL SYSTEM
Manufacturer
ARROWHEAD MEDICAL DEVICE TECHNOLOGIES LLC
Date Cleared
2011-12-12
(89 days)
Product Code
HTY
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
ARROWHEAD MEDICAL DEVICE TECHNOLOGIES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ARROW-LOK Digital Fusion System is indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures. It is not intended for use in the spine.
Device Description
The ARROW-LOK Digital Fusion device features a three dimensional arrow shape. The implants are available in multiple lengths with arrowheads of various diameters and in 2 different angles. The implant is manufactured from stainless steel and is designed for single use only.
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