510(k) K161913

AOS Small Fragment Plating System by Advanced Orthopaedic Solutions, Inc. (Aos) — Product Code HRS

K161913 is an FDA 510(k) premarket notification submitted by Advanced Orthopaedic Solutions, Inc. (Aos) for the device "AOS Small Fragment Plating System". The FDA issued a decision of Substantially Equivalent on November 4, 2016. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Advanced Orthopaedic Solutions, Inc. (Aos) has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2016
Date Received
July 12, 2016
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