510(k) K123562

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

K123562 is an FDA 510(k) premarket notification submitted by Flower Orthopedics Corporation for the device "FLOWER SMALL AND MEDIUM BONE IMPLANTS". The FDA issued a decision of Substantially Equivalent on March 29, 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
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