Cleared Traditional

Renova Spine Balloon Catheter

K231340 · Biopsybell S.R.L. · Orthopedic
Oct 2023
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K231340 is an FDA 510(k) clearance for the Renova Spine Balloon Catheter, a Cement, Bone, Vertebroplasty (Class II — Special Controls, product code NDN), submitted by Biopsybell S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on October 30, 2023, 174 days after receiving the submission on May 9, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K231340 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2023
Decision Date October 30, 2023
Days to Decision 174 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code NDN — Cement, Bone, Vertebroplasty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3027

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