510(k) K233696

DePuy Synthes Retrograde Femoral Nail Advanced System by DePuy Synthes — Product Code HSB

K233696 is an FDA 510(k) premarket notification submitted by DePuy Synthes for the device "DePuy Synthes Retrograde Femoral Nail Advanced System". The FDA issued a decision of Substantially Equivalent on August 1, 2024. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. DePuy Synthes has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2024
Date Received
November 17, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type