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510(k) K854191

MECRON UNCEMENTED STRUCTURED STEM HIP by Mecron Medical Products, Inc.

K854191 is an FDA 510(k) premarket notification submitted by Mecron Medical Products, Inc. for the device "MECRON UNCEMENTED STRUCTURED STEM HIP". The FDA issued a decision of Substantially Equivalent on November 13, 1985. Mecron Medical Products, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Mecron Medical Products, Inc.

  • K861138 — MASH DERMATOME (April 14, 1986)
  • K844775 — EFFNER-EYE CAUTERY WITH BATTERY HANDLE (August 12, 1985)
  • K844774 — EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS (April 22, 1985)
  • K844488 — MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS (March 12, 1985)
  • K844486 — MECRON MRC-HEADLESS FEMORAL COMPONENT (February 19, 1985)
  • K844487 — MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR (February 19, 1985)
  • K844773 — EFF-EFFNER BULBS (January 8, 1985)
  • K843449 — AUTODYNAMIC COMPRESSION HIP SCREW-PLATE (October 22, 1984)
  • K843553 — BONE PLATES (October 1, 1984)
  • K843554 — BONE SCREWS (October 1, 1984)

FDA data resources