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FDA 510(k), K030055, MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS
FDA 510(k), K030055, MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS
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510(K) Number: K030055
Device Name: MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS
Manufacturer: PATRICIA SANDBORN BERES
Device Classification Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Regulation Number: LPH
Classification Product Code: 01/06/2003
Date Received: 08/11/2003
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS
Manufacturer: PATRICIA SANDBORN BERES
Device Classification Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Regulation Number: LPH
Classification Product Code: 01/06/2003
Date Received: 08/11/2003
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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