FDA.reportPublic FDA data

510(k) K231340

Device
Renova Spine Balloon Catheter
Applicant
Biopsybell S.R.L.
510(k) number
K231340
Product code
NDN
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-30
Date received
2023-05-09
Regulation
888.3027
Classification name
Cement, Bone, Vertebroplasty
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Carlo Ricca Prandi Bellini
Address
Via A. Manuzio, 24 Mirandola IT 41037 41037

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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