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510(k) Data Aggregation
K Number
K023375Device Name
MODIFICATION TO ESOP CO-CR FEMORAL HEADS
Manufacturer
Date Cleared
2002-10-25
(17 days)
Product Code
Regulation Number
888.3358Why did this record match?
Applicant Name (Manufacturer) :
PRO-ACTIVE HEALTHCARE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ESOP® Co-Cr Femoral Heads are intended for use in degenerative and inflammatory arthritis of the hip joint, trauma, non-acute femoral neck fracture, revision of previously failed hip arthroplasties, and idiopathic avascular (osteo) necrosis where radiographic evidence shows there is sufficient sound bone to seat the prosthesis. This device is intended for cementless application.
Device Description
The Metallic Femoral Heads are intended to be adapted to special cones machined for this purpose. Femoral head are available in several diameters for use in full hip or intermediary replacement. The length of the neck on the femoral stem can be adjusted by using the heads available in different insertion depths (short, medium, long and extra-long collars), and of different diameters.
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