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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 a medical device manufactured by Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2017-11-14 under approval 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. It is manufactured by Synthes (USA) Products, LLC. The 510(k) number is K172157.

When was DePuy Synthes Femoral Recon Nail System approved by the FDA?

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

What company makes DePuy Synthes Femoral Recon Nail System?

DePuy Synthes Femoral Recon Nail System is manufactured by Synthes (USA) Products, LLC.

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.

Related Clinical Trials

NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT07554976 Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures RECRUITING NCT05523635 Post Market Clinical Evaluation of Gamma 4 COMPLETED NCT03720782 Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty ACTIVE_NOT_RECRUITING NCT07019662 Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach RECRUITING NCT06368700 The HYALEX Pivotal Study RECRUITING

Other Devices by Synthes (USA) Products, LLC

K161590MatrixRIB Fixation System K160167DePuy Synthes TFNA Augmentation System K170802TRAUMACEM™ V+ Injectable Bone Cement K153587Taps for Resorbable Screws K180213Titanium TomoFix Medial High Tibia Plate Anatomical K182154Depuy Synthes Femoral Neck System

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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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