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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 K231340
Device Name Renova Spine Balloon Catheter
Applicant
Biopsybell S.R.L.
Via A. Manuzio, 24
Mirandola,  IT 41037
Applicant Contact Carlo Ricca Prandi Bellini
Correspondent
Maytal Doo
Kneza Milosa, 79
Belgrade,  RS 11000
Correspondent Contact Maurizio Pantaleoni
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Code
HRX  
Date Received05/09/2023
Decision Date 10/30/2023
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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