510(k) K123562

FLOWER SMALL AND MEDIUM BONE IMPLANTS by Flower Orthopedics Corporation — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2013
Date Received
November 19, 2012
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