510(k) K131657

FLOWER SMALL AND MEDIUM IMPLANT SET by Flower Orthopedics Corporation — Product Code HRS

K131657 is an FDA 510(k) premarket notification submitted by Flower Orthopedics Corporation for the device "FLOWER SMALL AND MEDIUM IMPLANT SET". The FDA issued a decision of Substantially Equivalent on August 22, 2013. 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
August 22, 2013
Date Received
June 6, 2013
Clearance Type
Special
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