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FDA 510(k), K960425, BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX
FDA 510(k), K960425, BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX
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510(K) Number: K960425
Device Name: BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX
Manufacturer: ENDOTEC, INC.
Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemented
Regulation Number: 888.3350
Classification Product Code: JDI
Date Received: 01/29/1996
Decision Date: 10/03/1996
Regulation Medical Specialty: Orthopedic
Device Name: BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX
Manufacturer: ENDOTEC, INC.
Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemented
Regulation Number: 888.3350
Classification Product Code: JDI
Date Received: 01/29/1996
Decision Date: 10/03/1996
Regulation Medical Specialty: Orthopedic
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- Delivery: Approximately 1 to 2 weeks
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