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FDA 510(k)

RETROGRADE FEMORAL NAIL

K-Number: K132005 · 2013-09-10

ApplicantAdvanced Orthopaedic Solutions, Inc.
Decision Date2013-09-10
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RETROGRADE FEMORAL NAIL is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Orthopaedic Solutions, Inc.. It received FDA 510(k) clearance on 2013-09-10 under 510(k) number K132005. 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 RETROGRADE FEMORAL NAIL?

RETROGRADE FEMORAL NAIL is a medical device that received FDA 510(k) clearance on 2013-09-10. The listed applicant is Advanced Orthopaedic Solutions, Inc.. The 510(k) number is K132005.

When did RETROGRADE FEMORAL NAIL receive FDA 510(k) clearance?

RETROGRADE FEMORAL NAIL received FDA 510(k) clearance on 2013-09-10, under 510(k) number K132005.

Who is the listed applicant for RETROGRADE FEMORAL NAIL?

The FDA 510(k) record lists Advanced Orthopaedic Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RETROGRADE FEMORAL NAIL?

The FDA product code for RETROGRADE FEMORAL NAIL is HSB.

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Other records listing Advanced Orthopaedic Solutions, Inc. as applicant

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K202489AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating SystemK202099AOS Galileo™ Trochanteric Nail SystemK191598AOS ES Retrograde Femoral NailK160409AOS Anterolateral Proximal Humeral PlateK133081TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL NK123569ANTEGRADE FEMORAL NAIL

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Related Devices (Code: HSB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbHK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.

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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