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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 K050754
Device Name PRECIMED CANNULATED SCREW SYSTEM
Applicant
Precimed, Inc.
102 Pickering Way
Suite 508
Exton,  PA  19341
Applicant Contact BARBARA LYONS
Correspondent
Precimed, Inc.
102 Pickering Way
Suite 508
Exton,  PA  19341
Correspondent Contact BARBARA LYONS
Regulation Number888.3040
Classification Product Code
HWC  
Date Received03/23/2005
Decision Date 05/18/2005
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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