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510(k) Clearances
/ K854191
510(k) K854191
MECRON UNCEMENTED STRUCTURED STEM HIP by
Mecron Medical Products, Inc.
Clearance Details
Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1985
Date Received
August 12, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No
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— MECRON MRC-HEADLESS FEMORAL COMPONENT (February 19, 1985)
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— MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR (February 19, 1985)
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— EFF-EFFNER BULBS (January 8, 1985)
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— AUTODYNAMIC COMPRESSION HIP SCREW-PLATE (October 22, 1984)
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— BONE PLATES (October 1, 1984)
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— BONE SCREWS (October 1, 1984)