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510(k) Data Aggregation
K Number
K100857Device Name
FUSION MEDICAL RING LOCK SYSTEM
Manufacturer
Date Cleared
2010-05-27
(62 days)
Product Code
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
JOHN J RICCIO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Stabilization of fractures & Osteotomy Bone deformity correction of lower extremities Arthrodesis of the rear foot, mid foot, and ankle joint. Limb lengthening in pediatric and adults.
Device Description
The Fusion Medical Ring Lock system is a Circular Frame and Footplate system, used in lower extremity Stabilization and Deformity Correction. Wires are placed in the bone and attached to the frame with wire fixation bolts. The wires are then tensioned to support the bone. Rings are made of aluminum 6061 T6. Posts are used to capture wires that are elevated off the frame. Posts are made of 17-4 PH stainless steel. Washers are used to fine tune the elevation, and hinges are used for gradual correction of bone.
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