Search Results
Found 1 results
510(k) Data Aggregation
K Number
K955137Device Name
IM C-MENT ACETABULAR CAP
Manufacturer
Date Cleared
1996-10-10
(332 days)
Product Code
Regulation Number
888.3350Why did this record match?
Applicant Name (Manufacturer) :
IMPLANT IDEAS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IM C-Ment Acetabular Cup will be used in indications which are the same as that for other acetabular components of cemented total hip replacement systems. Specifically, the IM C-Ment Acetabular Cup is intended to resurface the acetabular socket in cases of femoral head and neck fractures, nonunion of femoral head and neck fractures, femoral head aseptic necrosis, osteoarthritis, rheumatoid arthritis and revision of failed prostheses.
The IM C-Ment Acetabular Cup is intended to be used in cemented applications only.
Device Description
The IM C-Ment Acetabular Cup is an all-polyethylene, hemispherical acetabular component with three (3) concentric grooves on the outer diameter and 3 circular indentations equally-spaced around the circumference near the middle of the cup. It is provided in eleven (11) sizes for the 28mm inner diameter, ranging from outer diameters of 40mm to 60mm.
Ask a Question
Ask a specific question about this device
Page 1 of 1