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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K851214
Device Name T-SCREW
Applicant
Northeast Iowa Podiatry
St. Francis Professional Bldg.
Suite 105
Waterloo,  IA  50702
Applicant Contact LICHTY
Correspondent
Northeast Iowa Podiatry
St. Francis Professional Bldg.
Suite 105
Waterloo,  IA  50702
Correspondent Contact LICHTY
Regulation Number888.3040
Classification Product Code
HWC  
Date Received03/26/1985
Decision Date 04/22/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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