Cleared Special

V-STRUT? Vertebral Implant

K240084 · Hyprevention · Orthopedic

Feb 2024

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K240084 is an FDA 510(k) clearance for the V-STRUT? Vertebral Implant, a Cement, Bone, Vertebroplasty (Class II — Special Controls, product code NDN), submitted by Hyprevention (Pessac, FR). The FDA issued a Cleared decision on February 9, 2024, 29 days after receiving the submission on January 11, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number	K240084 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 11, 2024
Decision Date	February 09, 2024
Days to Decision	29 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF