510(k) K120148

AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREW by Advanced Orthopaedic Solutions, Inc. — Product Code HSB

K120148 is an FDA 510(k) premarket notification submitted by Advanced Orthopaedic Solutions, Inc. for the device "AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREW". The FDA issued a decision of Substantially Equivalent on October 2, 2012. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Advanced Orthopaedic Solutions, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2012
Date Received
January 18, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type