Cleared Traditional

NET BRAND Osteosynthesis Nailing System

K233150 · Narang Medical , Ltd. · Orthopedic

Feb 2024

Decision

146d

Days

Class 2

Risk

About This 510(k) Submission

K233150 is an FDA 510(k) clearance for the NET BRAND Osteosynthesis Nailing System, a Nail, Fixation, Bone (Class II — Special Controls, product code JDS), submitted by Narang Medical , Ltd. (Delhi, IN). The FDA issued a Cleared decision on February 20, 2024, 146 days after receiving the submission on September 27, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K233150 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2023
Decision Date	February 20, 2024
Days to Decision	146 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF