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510(k) K834499

SHEATHS FOR REINFORCING BONE CEMENT by Mecron Medical Products, Inc.

K834499 is an FDA 510(k) premarket notification submitted by Mecron Medical Products, Inc. for the device "SHEATHS FOR REINFORCING BONE CEMENT". The FDA issued a decision of Substantially Equivalent on April 24, 1984. Mecron Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1984
Date Received
December 20, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Mecron Medical Products, Inc.

  • K861138 — MASH DERMATOME (April 14, 1986)
  • K854191 — MECRON UNCEMENTED STRUCTURED STEM HIP (November 13, 1985)
  • 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)
  • K844487 — MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR (February 19, 1985)
  • K844486 — MECRON MRC-HEADLESS FEMORAL COMPONENT (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)

FDA data resources