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FDA 510(k)

DePuy Synthes Femoral Recon Nail System

K-Number: K172157 · 2017-11-14

ApplicantSynthes (USA) Products, LLC
Decision Date2017-11-14
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DePuy Synthes Femoral Recon Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2017-11-14 under 510(k) number K172157. 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 DePuy Synthes Femoral Recon Nail System?

DePuy Synthes Femoral Recon Nail System is a medical device that received FDA 510(k) clearance on 2017-11-14. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K172157.

When did DePuy Synthes Femoral Recon Nail System receive FDA 510(k) clearance?

DePuy Synthes Femoral Recon Nail System received FDA 510(k) clearance on 2017-11-14, under 510(k) number K172157.

Who is the listed applicant for DePuy Synthes Femoral Recon Nail System?

The FDA 510(k) record lists Synthes (USA) Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DePuy Synthes Femoral Recon Nail System?

The FDA product code for DePuy Synthes Femoral Recon Nail System is HSB.

Other records listing Synthes (USA) Products, LLC as applicant

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemK212943SyntheCel Dura RepairK211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)K210408DePuy Synthes Variable Angle Locking Patella Plating SystemK210205DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating SystemK201346DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm

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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.

K261481Pangea Femur Reconstruction SystemStryker GmbHK261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix Srl

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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