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FDA 510(k)

AOS ES Retrograde Femoral Nail

K-Number: K191598 · 2019-07-18

ApplicantAdvanced Orthopaedic Solutions, Inc.
Decision Date2019-07-18
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AOS ES Retrograde Femoral Nail is a medical device manufactured by Advanced Orthopaedic Solutions, Inc.. It received FDA 510(k) clearance on 2019-07-18 under approval number K191598. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AOS ES Retrograde Femoral Nail?

AOS ES Retrograde Femoral Nail is a medical device that received FDA 510(k) clearance on 2019-07-18. It is manufactured by Advanced Orthopaedic Solutions, Inc.. The 510(k) number is K191598.

When was AOS ES Retrograde Femoral Nail approved by the FDA?

AOS ES Retrograde Femoral Nail received FDA 510(k) clearance on 2019-07-18, under approval number K191598.

What company makes AOS ES Retrograde Femoral Nail?

AOS ES Retrograde Femoral Nail is manufactured by Advanced Orthopaedic Solutions, Inc..

What is the FDA product code for AOS ES Retrograde Femoral Nail?

The FDA product code for AOS ES Retrograde Femoral Nail is HSB.

Other Devices by Advanced Orthopaedic Solutions, Inc.

K160409AOS Anterolateral Proximal Humeral Plate K202489AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System K202099AOS Galileo™ Trochanteric Nail System

Related Devices (Code: HSB)

K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc. K160545GAP ENDO-EXO MEDULLARY SYSTEMPega Medical, Inc. K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. K160267PRECICE Trauma Nail SystemEllipse Technologies, Incorporated

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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