510(k) K172872

DePuy Synthes Femoral Neck System by DePuy Synthes — Product Code KTT

K172872 is an FDA 510(k) premarket notification submitted by DePuy Synthes for the device "DePuy Synthes Femoral Neck System". The FDA issued a decision of Substantially Equivalent on March 5, 2018. The device falls under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component), a Class II device regulated under 21 CFR 888.3030. DePuy Synthes has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2018
Date Received
September 21, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type