Cleared Traditional

Caliber Intramedullary Fixation System

K242896 · Nvision Biomedical Technologies · Orthopedic

Feb 2025

Decision

135d

Days

Class 2

Risk

About This 510(k) Submission

K242896 is an FDA 510(k) clearance for the Caliber Intramedullary Fixation System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Nvision Biomedical Technologies (San Antonio, US). The FDA issued a Cleared decision on February 5, 2025, 135 days after receiving the submission on September 23, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K242896 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 23, 2024
Decision Date	February 05, 2025
Days to Decision	135 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF