510(k) K133081

TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N by Advanced Orthopaedic Solutions, Inc. — Product Code HSB

K133081 is an FDA 510(k) premarket notification submitted by Advanced Orthopaedic Solutions, Inc. for the device "TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N". The FDA issued a decision of Substantially Equivalent on December 31, 2013. 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
December 31, 2013
Date Received
September 30, 2013
Clearance Type
Special
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