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510(k) K962553

EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM by Biodynamic Technologies, Inc. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1996
Date Received
July 1, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

Other clearances by Biodynamic Technologies, Inc.

  • K990436 — ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM (March 31, 1999)
  • K990481 — ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM (March 17, 1999)
  • 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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