510(k) K140018

TSP HIP FRACTURE PLATING SYSTEM by Biomet, Inc. — Product Code JDO

K140018 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "TSP HIP FRACTURE PLATING SYSTEM". The FDA issued a decision of Substantially Equivalent on April 4, 2014. 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
April 4, 2014
Date Received
January 3, 2014
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