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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 K080778
Device Name ENSPLINT TM BONE SCREW
Applicant
Sonoma Orthopedic Products, Inc.
650 Larkfield Center
Santa Rosa,  CA  95403
Applicant Contact AMY CONUEL
Correspondent
Sonoma Orthopedic Products, Inc.
650 Larkfield Center
Santa Rosa,  CA  95403
Correspondent Contact AMY CONUEL
Regulation Number888.3040
Classification Product Code
HWC  
Date Received03/19/2008
Decision Date 07/10/2008
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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