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510(k) Data Aggregation
K Number
K041353Device Name
FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM
Manufacturer
JRI MANUFACTURING LTD
Date Cleared
2004-10-08
(141 days)
Product Code
MEH
Regulation Number
888.3353Why did this record match?
Applicant Name (Manufacturer) :
JRI MANUFACTURING LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Indications for the Furloug® H-AC Total Hip Replacement System are:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis .
- Correction off functional deformity .
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- Revision procedures where other treatments or devices have failed. .
Device Description
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