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510(k) Data Aggregation
K Number
K051957Device Name
REPROCESSED EXTERNAL FIXATION DEVICE
Manufacturer
Date Cleared
2005-09-21
(68 days)
Product Code
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
STERILEMED INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Reprocessed External Fixation Device is intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation.
LARGE: Provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components are used for: Stabilization of soft tissues and fractures, Polytrauma/multiple orthopedic trauma, As treatment adjunct for vertically unstable pelvic fractures, Arthrodeses and osteotomies with soft tissue problems; failures of total joints, Treatment of fractures stabilized with limited internal fixation, Non-unions/septic non-unions, Intra-operative reductions/stabilization tool to assist with indirect reduction, Unilateral rectilinear bone segment transport or leg lengthening.
MEDIUM: Indicated for construction of an external fixation frame for the treatment of pediatric and adult fractures.
SMALL: Stabilizes and provides treatment for fractures of the small bones, such as the hand, wrist, and foot. Specifically, the components can be used for: Preliminary fixation before ORIF, Unstable fractures of the distal radius (both intra and extra-articular), Open and/or comminuted bilateral fractures, Open and or combination with extensive soft tissue injury, bone loss, and vascular and/or neural involvement, Fracture dislocations, Failed closed reduction with casting resulting in secondary deformity (radial shortening and angulations), Pediatric open fractures with bone loss and osteotomies.
MINI: Stabilizes and provides treatment for fractures of the hand and foot. Specifically, the components can be used for: Comminuted fractures of phalanges and metacarpals, Displaced intra-articular fractures, Segmental bone loss, Fractures that do not allow stable internal fixation, Fractures with associated complex soft tissue injuries, Tumor resections.
Device Description
The Reprocessed External Fixation Device consists of the standard bridge elements (rods, articulating and telescoping components), and connection elements (clamps) contained in the original manufacturer's system. Some of the components are MR safe and made of non-magnetic materials. MR safe components are intended for use in the MR environment. Anchorage elements are not included in the Reprocessed External Fixation Device.
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