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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, Antibiotic
510(k) Number K201960
Device Name SpaceFlex Knee - 80mm Size
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 Sands
Regulation Number888.3027
Classification Product Code
MBB  
Subsequent Product Code
JWH  
Date Received07/14/2020
Decision Date 08/13/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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