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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pin, fixation, threaded
510(k) Number K970751
Device Name HEIDELBERG EXTERNAL FIXATOR
Applicant
SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Applicant Contact JOANNE KHUNE
Correspondent
SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Correspondent Contact JOANNE KHUNE
Regulation Number888.3040
Classification Product Code
JDW  
Date Received03/03/1997
Decision Date 04/16/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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