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510(k) Data Aggregation
K Number
K111993Device Name
FRAMEWALKER
Manufacturer
Date Cleared
2011-10-24
(103 days)
Product Code
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
QUANTUM MEDICAL CONCEPTS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device is indicated for use in patients who are undergoing external ring fixation of the Foot and Ankle for the following conditions: For use in the treatment of fracture fixation (open and closed), pseudarthrosis or nonunions of long bones, limb lengthening hy distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects.
Device Description
Framewalker is a "Single Use" walking aid designed to the foot ring portion of an external ring fixator. The Framewalker is intended for patients who are undergoing procedures requiring ring fixation of the lower extremity. The device is applied to the foot ring portion of a ring fixation frame in order to provide a stable platform below the foot to both protect the bottom of the foot and to allow a patient limited ambulation during treatment as determined by a physician.
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K Number
K101759Device Name
QUANTUM RING FIXATION SYSTEM MODEL ISF
Manufacturer
Date Cleared
2010-10-22
(121 days)
Product Code
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
QUANTUM MEDICAL CONCEPTS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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