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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 K181282
Device Name G3A 40 Bone Cement
Applicant
G21, S.R.L.
Via Sandro Petrini, 8
San Possidomio,  IT 41039
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 Received05/15/2018
Decision Date 01/09/2019
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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