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510(k) K954838

EZ FIX by Biodynamic Technologies, Inc. — Product Code JEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1996
Date Received
October 20, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, Traction, Invasive
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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  • K990513 — ULTIMAX CORTICAL BONE SCREWS (March 17, 1999)
  • K981230 — ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM (June 1, 1998)
  • K980102 — BTI HUMERAL INTRAMEDULLARY ROD SYSTEM (April 3, 1998)
  • K974756 — BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS (March 12, 1998)
  • K972403 — BTI CORTICAL BONE SCREWS (August 29, 1997)
  • K970897 — BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM (April 21, 1997)
  • K962706 — EZ-FIX CANNULATED SCREW SYSTEM (November 13, 1996)
  • K962987 — EZ-FIX SMALL CANNULATED SCREW SYSTEM (November 4, 1996)

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