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510(k) Data Aggregation
K Number
K112658Device Name
OSTEOSPRING FOOTJACK SUBTALAR IMPLANT SYSTEM
Manufacturer
Date Cleared
2011-12-12
(90 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
OSTEOSPRING MEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The OsteoSpring FootJack™ Subtalar Implant System is indicated for use in the treatment of hyperpronated foot and stabilization of the subtalar joint. It is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion but limited excessive pronation and resulting sequela. The OsteoSpring FootJack Implant System . implants are intended for single patient use only.
Device Description
The OsteoSpring FootJack™ subtalar implant is intended to be implanted into the sinus tarsi of the foot. It will be available in a range of sizes. The implant is a solid, one-piece, conical, thread shaped and cannulated design.
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