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FDA 510(k)

SYNTEC HUMERAL NAIL SYSTEM

K-Number: K161327 · 2017-06-08

ApplicantSyntec Scientific Corporation
Decision Date2017-06-08
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTEC HUMERAL NAIL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Syntec Scientific Corporation. It received FDA 510(k) clearance on 2017-06-08 under 510(k) number K161327. 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 HUMERAL NAIL SYSTEM?

SYNTEC HUMERAL NAIL SYSTEM is a medical device that received FDA 510(k) clearance on 2017-06-08. The listed applicant is Syntec Scientific Corporation. The 510(k) number is K161327.

When did SYNTEC HUMERAL NAIL SYSTEM receive FDA 510(k) clearance?

SYNTEC HUMERAL NAIL SYSTEM received FDA 510(k) clearance on 2017-06-08, under 510(k) number K161327.

Who is the listed applicant for SYNTEC HUMERAL NAIL SYSTEM?

The FDA 510(k) record lists Syntec Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTEC HUMERAL NAIL SYSTEM?

The FDA product code for SYNTEC HUMERAL NAIL SYSTEM is HSB.

Other records listing Syntec Scientific Corporation 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.

K202790Syntec Orthodontic Mini Screw Extended SystemK202935Syntec Femoral Nail Extended SystemK200933Syntec Non-Sterile Steinmann Pins SystemK191617Syntec Tibial Nail SystemK181296Syntec Femoral Nail System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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