Aos Tibial Nail

FDA 510(k) K070444 · Advanced Orthopaedic Solutions, Inc.

Substantially Equivalent

510(k) numberK070444

Submission

Device name
Aos Tibial Nail
Applicant
Advanced Orthopaedic Solutions, Inc.
Torrance, CA, US
Received
February 15, 2007
Decision date
June 14, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HSB – Rod, Fixation, Intramedullary And Accessories
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3020
Specialty
Orthopedic
Implant
Yes

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More from Fusion Orthopedics USA, LLC

510(k)DeviceDecision
K202489AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating SystemHRS · Traditional 10/26/2020SE
K202099AOS Galileo™ Trochanteric Nail SystemHSB · Special 08/28/2020SE
K191598AOS ES Retrograde Femoral NailHSB · Special 07/18/2019SE
K182466AOS Calcaneal Plating SystemHRS · Traditional 10/30/2018SE
K160409AOS Anterolateral Proximal Humeral PlateKTW · Special 03/15/2016SE
K143204AOS Clavicle Intramedullary DeviceHSB · Traditional 06/03/2015SE
K141912Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation…KTT · Traditional 10/29/2014SE
K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewHSB · Traditional 07/08/2014SE
K133081Trochanteric Nails and Es Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…HSB · Special 12/31/2013SE
K132005Retrograde Femoral NailHSB · Traditional 09/10/2013SE

Questions and answers

When was Aos Tibial Nail cleared by the FDA?

Aos Tibial Nail (K070444) received a 510(k) decision of Substantially Equivalent on June 14, 2007, 119 days after the submission was received.

What is the product code of K070444?

The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.