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510(k) Data Aggregation
K Number
K221697Device Name
INJECTION PIN (KIP(02031-02061) (03031-03061))
Manufacturer
SLK Ortho Llc
Date Cleared
2023-03-03
(266 days)
Product Code
NDN, LOD
Regulation Number
888.3027Why did this record match?
Applicant Name (Manufacturer) :
SLK Ortho Llc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Injection Pin, is indicated for fractures caused by severe osteoporosis, trauma, and tumors of the thoracic/lumbar spine from T9-L5. Injection Pin is indicated for use in combination with PMMA bone cement (Teknimed F200) for the treatment of fractures caused by trauma, osteoporosis, or turnors in the thoracic/lumbar spine from T9-L5.
Device Description
The Injection Pin is a single piece of Titanium alloy (Ti 6Al 4V) that complies with ISO 5832-3 and ASTM F136. It is a fenestrated screw that is cannulated along its entire length, with lateral holes along the body that do not interfere or affect the threads. The spherical head of the screw has an internal hexagon for firm coupling with the insertion screwdriver (REF IPST0007).
The Injection Pin implant is a medical device to be placed in the thoracolumbar region through a minimally invasive procedure. This device being cannulated and fenestrated permits the use, when applicable, for the introduction of approved PMMA (Teknimed F20®). It is available in both 5 and 6mm diameters and in lengths 31-61mm in 3mm increments.
The Injection Pin is easily seen Intra-Operatively as well as post-Op with good visualization.
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