FDA 510(k), K053536, DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
FDA 510(k), K053536, DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
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510(K) Number: K053536
Device Name: DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
Manufacturer:
Device Classification Name: Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Regulation Number: 888.3330
Classification Product Code: KWA
Date Received: 12/19/2005
Decision Date: 03/16/2006
Regulation Medical Specialty: Orthopedic
Device Name: DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
Manufacturer:
Device Classification Name: Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Regulation Number: 888.3330
Classification Product Code: KWA
Date Received: 12/19/2005
Decision Date: 03/16/2006
Regulation Medical Specialty: Orthopedic