Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Syntec Scientific Corporation. It received FDA 510(k) clearance on 2017-06-08 under approval 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. It is manufactured by Syntec Scientific Corporation. The 510(k) number is K161327.

When was SYNTEC HUMERAL NAIL SYSTEM approved by the FDA?

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

What company makes SYNTEC HUMERAL NAIL SYSTEM?

SYNTEC HUMERAL NAIL SYSTEM is manufactured by Syntec Scientific Corporation.

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

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

Related Clinical Trials

NCT05019664 Affixus Natural Nail System Humeral Nail PMCF ACTIVE_NOT_RECRUITING NCT05773352 Perform® Humeral System - Fracture Study (PFX) ACTIVE_NOT_RECRUITING NCT05500066 Tornier HRS (Humeral Reconstruction System) Study (REVIVE) ENROLLING_BY_INVITATION

Other Devices by Syntec Scientific Corporation

K191617Syntec Tibial 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.

↑