510(k) K173826

THP Hip Fracture Plating System by Biomet, Inc. — Product Code JDO

K173826 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "THP Hip Fracture Plating System". The FDA issued a decision of Substantially Equivalent on February 7, 2018. The device falls under product code JDO (Device, Fixation, Proximal Femoral, Implant), a Class II device regulated under 21 CFR 888.3030. Biomet, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2018
Date Received
December 18, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Fixation, Proximal Femoral, Implant
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type