FDA 510(k) Application Details - K962846

Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

  More FDA Info for this Device
510(K) Number K962846
Device Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Applicant BIODYNAMIC TECHNOLOGIES, INC.
1425 EAST NEWPORT CENTER DR.
DEERFIELD BEACH, FL 33442 US
Other 510(k) Applications for this Company
Contact DANNY HODGEMAN
Other 510(k) Applications for this Contact
Regulation Number 888.3030

  More FDA Info for this Regulation Number
Classification Product Code LXT
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 07/22/1996
Decision Date 10/23/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact