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510(k) Data Aggregation
K Number
K052320Device Name
ENCORE CLP OFFSET TOTAL HIP SYSTEM
Manufacturer
Date Cleared
2005-12-30
(127 days)
Regulation Number
888.3330Why did this record match?
Applicant Name (Manufacturer) :
ENCORE MEDICAL CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Encore CLP Total Hip System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post - traumatic arthritis, collagen disorders, avascular necrosis, Protrusio Acetabuli, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip displasia, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
The Encore CLP Offset Hip Stem is intended for Cementless Applications
Device Description
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