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FDA 510(k)

Syntec Femoral Nail System

K-Number: K181296 · 2019-04-11

ApplicantSyntec Scientific Corporation
Decision Date2019-04-11
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Syntec Femoral Nail System is a medical device manufactured by Syntec Scientific Corporation. It received FDA 510(k) clearance on 2019-04-11 under approval number K181296. 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 Syntec Femoral Nail System?

Syntec Femoral Nail System is a medical device that received FDA 510(k) clearance on 2019-04-11. It is manufactured by Syntec Scientific Corporation. The 510(k) number is K181296.

When was Syntec Femoral Nail System approved by the FDA?

Syntec Femoral Nail System received FDA 510(k) clearance on 2019-04-11, under approval number K181296.

What company makes Syntec Femoral Nail System?

Syntec Femoral Nail System is manufactured by Syntec Scientific Corporation.

What is the FDA product code for Syntec Femoral Nail System?

The FDA product code for Syntec Femoral 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 Syntec Scientific Corporation

K161327SYNTEC HUMERAL NAIL SYSTEM K191617Syntec Tibial Nail System K202935Syntec Femoral Nail Extended System K200933Syntec Non-Sterile Steinmann Pins System K202790Syntec Orthodontic Mini Screw Extended 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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