Medical Products Inc. / Radiological HeIalth Enrclosure TUM Medical Inc / Consensus TaperSet Hip System Consensus Orthopedics Inc. / Dennis Crane Emerson Consultants Inc / L4 TOM Medical Inc. / K100933 C52 Plus Acetabular Insert Consensus Orthopedics Inc. / System U.S. Medical Products Inc. / Consensus Orthopedics Inc. / Head U.S. Medical Products Inc. / Name U.S. Medical Products Inc. / Hayes Medical Inc. / TOM Medical Inc. / KI 11472 Trade / / / /
IndustryTerm
subject device / 10oint1 metal/polymer/metal / joint metal/polymer/metal / marketed predicate devices / announFcements concerning your device / oood manufacturing practice / marketed devices / Internet address / metal shell / /
MedicalCondition
D. Avascular necrosis / post-traumatic arthritis / osteoporosis / stem fatigue / coxa plana / /
Organization
Division of Sma!lI N/lanu-factUrcrs / office of Compliance / CDRIl's office of SurVei IIance / office of Device Evaluation / FDA / DEPARTMENT OF HEALTH / N. Melkerson Director Division of SUr-gical / Orthopedic / and Restorative Devices office / /
Person
Mark N. Melkerson / / /
Position
CoCr femoral head / femoral head / HHS CoCr head / HI-S CoCr femoral head / /
TOM Medical, IncPaeIo3 Premarket Traditional 5 10(k) Notification: HELICON Hip SystemPae1o3[removed]k) SUMMARY Sponsor Name: