Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Cement, Bone, Vertebroplasty
510(k) Number K152557
Device Name Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters
Applicant
G21, S.R.L.
Via S. Pertini, 8
San Possidonio,  IT 41039
Applicant Contact Maurizio Foroni
Correspondent
RQMIS, Inc.
29 Water St.
Suite 305
Newburyport,  MA  01950
Correspondent Contact Barry E Sands
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Code
HRX  
Date Received09/08/2015
Decision Date 02/23/2016
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
-
-