510(k) K181035

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

K181035 is an FDA 510(k) premarket notification submitted by Advanced Orthopaedic Solutions, Inc. (Aos) for the device "AOS Small Fragment Plating System Lite". The FDA issued a decision of Substantially Equivalent on August 24, 2018. 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
August 24, 2018
Date Received
April 18, 2018
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