Cleared Traditional

Balloon Inflation System

K232842 · Ningbo Hicren Biotechnology Co., Ltd. · Orthopedic

Feb 2024

Decision

168d

Days

Class 2

Risk

About This 510(k) Submission

K232842 is an FDA 510(k) clearance for the Balloon Inflation System, a Cement, Bone, Vertebroplasty (Class II — Special Controls, product code NDN), submitted by Ningbo Hicren Biotechnology Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on February 29, 2024, 168 days after receiving the submission on September 14, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number	K232842 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 14, 2023
Decision Date	February 29, 2024
Days to Decision	168 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF