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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 K973810
Device Name DRG LARGE SCREW SYSTEM
Applicant
Dolphin Medical Technologies, Inc.
5959 Cattlemen Ln.
Sarasota,  FL  34232
Applicant Contact MARK G URBANSKI
Correspondent
Dolphin Medical Technologies, Inc.
5959 Cattlemen Ln.
Sarasota,  FL  34232
Correspondent Contact MARK G URBANSKI
Regulation Number888.3040
Classification Product Code
HWC  
Date Received10/07/1997
Decision Date 01/05/1998
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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