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FDA 510(k)

Syntec Tibial Nail System

K-Number: K191617 · 2019-09-03

ApplicantSyntec Scientific Corporation
Decision Date2019-09-03
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Syntec Tibial Nail System is a medical device manufactured by Syntec Scientific Corporation. It received FDA 510(k) clearance on 2019-09-03 under approval number K191617. 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 Tibial Nail System?

Syntec Tibial Nail System is a medical device that received FDA 510(k) clearance on 2019-09-03. It is manufactured by Syntec Scientific Corporation. The 510(k) number is K191617.

When was Syntec Tibial Nail System approved by the FDA?

Syntec Tibial Nail System received FDA 510(k) clearance on 2019-09-03, under approval number K191617.

What company makes Syntec Tibial Nail System?

Syntec Tibial Nail System is manufactured by Syntec Scientific Corporation.

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

The FDA product code for Syntec Tibial Nail System is HSB.

Related Clinical Trials

NCT07456865 Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device RECRUITING NCT04358601 All-poly Versus Metal-backed ACTIVE_NOT_RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT03720782 Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty ACTIVE_NOT_RECRUITING

Other Devices by Syntec Scientific Corporation

K161327SYNTEC HUMERAL NAIL SYSTEM K181296Syntec Femoral 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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