510(k) K233150

NET BRAND Osteosynthesis Nailing System by Narang Medical , Ltd. — Product Code JDS

K233150 is an FDA 510(k) premarket notification submitted by Narang Medical , Ltd. for the device "NET BRAND Osteosynthesis Nailing System". The FDA issued a decision of Substantially Equivalent on February 20, 2024. The device falls under product code JDS (Nail, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2024
Date Received
September 27, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nail, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type