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510(k) K990481

ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM by Biodynamic Technologies, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1999
Date Received
February 16, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Biodynamic Technologies, Inc.

  • K990436 — ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM (March 31, 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)
  • K962846 — EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM (October 23, 1996)

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