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510(k) Data Aggregation
K Number
K241769Device Name
Response Ortho Metaphyseal Hinge Fixator System
Manufacturer
Response Ortho Solutions LLC
Date Cleared
2024-09-18
(90 days)
Product Code
KTT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Response Ortho Solutions LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Response Ortho Metaphyseal Fixation System is indicated for treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation.
Device Description
The Response Ortho Metaphyseal Hinge Fixator System is a unilateral fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. The system is designed to provide low profile and comprehensive solution invasively. Implants, reusable instruments, accessories, case&tray are included in the system. Products are non-sterile and implants that exist in the set, are single use. Instruments that are in the system, can be used repeatedly after cleaning and sterilization.
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