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510(k) Data Aggregation
K Number
K060026Device Name
KOBY SURGICAL INTERNAL FIXATION SYSTEM
Manufacturer
KOBY SURGICAL
Date Cleared
2006-01-26
(22 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
KOBY SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Koby Surgical Internal Fixation System implants are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot. The implants are intended for single use only.
These implants are not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Device Description
The Koby Surgical Internal Fixation System consists of a series of cannulated and non-cannulated bone screws which vary in diameters and lengths. These screws are constructed from implant-grade titanium and are used to aid in the fixation of bones in the upper and lower extremities.
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