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510(k) Data Aggregation
K Number
K222505Device Name
CurvaFix IM System
Manufacturer
Date Cleared
2022-10-27
(70 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
CurvaFix, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CurvaFix® IM System is intended for fixation of fractures of the pelvis.
Device Description
The CurvaFix IM System is a collection of flexible intramedullary devices for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the IM Implant from a flexible to rigid state after implantation. The IM Implant can be returned to a flexible state should device explant be required. The implants are available in two diameters (7.5mm and 9.5mm) and lengths ranging from 90mm to 180mm to accommodate a variety of anatomic requirements.
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K Number
K180050Device Name
CurvaFix Intramedullary Rodscrew System
Manufacturer
Date Cleared
2019-03-01
(417 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
CurvaFix, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CurvaFix® Intramedullary Rodscrew is intended for fixation of fractures of the pelvis.
Device Description
The CurvaFix Intramedullary Rodscrew System is a collection of flexible intramedullary devices for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the Rodscrew from a flexible to rigid state after implantation. The Rodscrew can be returned to a flexible state should explantation be required. The implants are available in a single diameter and an assortment of lengths to accommodate a variety of anatomic requirements.
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