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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 K984331
Device Name ODI ULTIMATE COMPRESSION HIP SCREW
Applicant
Orthopedic Designs, Inc.
6971 1st. Ave. N.
St. Petersburg,  FL  33710
Applicant Contact JEFF GODSTED
Correspondent
Orthopedic Designs, Inc.
6971 1st. Ave. N.
St. Petersburg,  FL  33710
Correspondent Contact JEFF GODSTED
Regulation Number888.3040
Classification Product Code
HWC  
Date Received12/03/1998
Decision Date 01/20/1999
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
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