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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K010322
Device Name ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
Applicant
Orthodyne, Inc.
1118 So. Orange Ave.
Suite 204
Orlando,  FL  32806
Applicant Contact CARL KNOBLOCH
Correspondent
Orthodyne, Inc.
1118 So. Orange Ave.
Suite 204
Orlando,  FL  32806
Correspondent Contact CARL KNOBLOCH
Regulation Number888.3020
Classification Product Code
HSB  
Date Received02/02/2001
Decision Date 05/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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