510(k) K142306

Flower Upper Extremity Plating Set by Flower Orthopedics Corporation — Product Code HRS

K142306 is an FDA 510(k) premarket notification submitted by Flower Orthopedics Corporation for the device "Flower Upper Extremity Plating Set". The FDA issued a decision of Substantially Equivalent on September 15, 2014. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Flower Orthopedics Corporation has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2014
Date Received
August 19, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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