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510(k) K870333

BIODYNAMICS SMALL JOINT BRUSH #1203 by Biodynamic Technologies, Inc. — Product Code HTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1987
Date Received
January 28, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rasp
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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  • K981230 — ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM (June 1, 1998)
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  • 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)
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Other clearances for product code HTR

  • K870329 — ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202 (February 13, 1987)
  • K870349 — BIODYNAMICS FEMORAL CANAL BRUSH #1201 (February 13, 1987)
  • K813093 — RICHARDS ACETABULAR BRUSH (November 20, 1981)
  • K812506 — THE ARTHROFILE (September 24, 1981)
  • K780771 — MICRO RASPS (May 16, 1978)
  • K771016 — INTERMEDULLARY BRUSH (January 12, 1978)
  • K771745 — RASPS FOR SCRAPING BONE (September 28, 1977)
  • K760109 — PROSTHESIS, TOTAL HIP-RASP (July 20, 1976)