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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Cement
510(k) Number K173494
Device Name OrthoSteady G Bone Cement
Applicant
G21, S.R.L.
Via Sandro Petrini, 8
San Possidonio,  IT 841039
Applicant Contact Filippo Foroni
Correspondent
RQMIS, Inc.
110 Haverhill Rd., Suite 526
Amesbury,  MA  01913
Correspondent Contact Barry E. Sands
Regulation Number888.3027
Classification Product Code
LOD  
Subsequent Product Code
MBB  
Date Received11/13/2017
Decision Date 03/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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