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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Bone, Vertebroplasty
510(k) Number K172214
Device Name Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters
Applicant
G-21 S.R.L.
Via S. Pertini, 8
San Possidonio,  IT 41039
Applicant Contact Maurizio Foroni
Correspondent
RQMIS, Inc.
110 Haverhill Rd., Suite 526
Amesbury,  MA  01913
Correspondent Contact Paul Speidel
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Code
HRX  
Date Received07/24/2017
Decision Date 08/23/2017
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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