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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 K193059
Device Name G1 40 Radiopaque Bone Cement
Applicant
G21, S.R.L.
Via S. Pertini, 8
San Possidonio,  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  
Date Received11/01/2019
Decision Date 03/19/2020
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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