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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 K142528
Device Name AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mm
Applicant
Agent Medical, LLC
1145 Gaskins Rd., Suite 102
Richmond,  VA  23238
Applicant Contact Scott Munday
Correspondent
Engineering Consulting Services, Inc.
3150 E. 200th. St.
Prior Lake,  MN  55372
Correspondent Contact Al Lippincott
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/09/2014
Decision Date 12/22/2014
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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