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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 K192041
Device Name G21 SpaceFlex Hip
Applicant
G21 S.r.l
Via Sandro Petrini, 8
san possidonio,  IT 41039
Applicant Contact filippo foroni
Correspondent
RQMIS, Inc.
110 Haverhill Road, Suite #526
amesbury,  MA  01860
Correspondent Contact barry sands
Regulation Number888.3027
Classification Product Code
MBB  
Subsequent Product Codes
KWL   KWY  
Date Received07/31/2019
Decision Date 10/29/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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