Cleared Traditional

GENTAFIX? (1, 3, 3MV)

K242216 · Teknimed Sas · Orthopedic

Dec 2024

Decision

142d

Days

Class 2

Risk

About This 510(k) Submission

K242216 is an FDA 510(k) clearance for the GENTAFIX? (1, 3, 3MV), a Bone Cement, Antibiotic (Class II — Special Controls, product code MBB), submitted by Teknimed Sas (L'Union, FR). The FDA issued a Cleared decision on December 18, 2024, 142 days after receiving the submission on July 29, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number	K242216 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 29, 2024
Decision Date	December 18, 2024
Days to Decision	142 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF