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510(k) K962846

EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM by Biodynamic Technologies, Inc. — Product Code LXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1996
Date Received
July 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Biodynamic Technologies, Inc.

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  • K990513 — ULTIMAX CORTICAL BONE SCREWS (March 17, 1999)
  • K990481 — ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM (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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  • K112345 — DISTAL VOLAR RADIUS PLATING SYSTEMS (October 31, 2011)
  • K090374 — STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 (March 11, 2009)
  • K073135 — SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS (January 29, 2008)
  • K063832 — SYNTHES (USA) ELBOW HINGE FIXATOR (March 7, 2007)
  • K060864 — MULTIDIRECTIONAL THREADED PEG (April 28, 2006)
  • K060403 — PTA (PROGRESSIVE TIBIAL ALIGNMENT) (March 28, 2006)
  • K060290 — SHOULDER FIXATION SYSTEM (February 27, 2006)