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FDA 510(k)

Syntec Orthodontic Mini Screw Extended System

K-Number: K202790 · 2021-09-17

ApplicantSyntec Scientific Corporation
Decision Date2021-09-17
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Syntec Orthodontic Mini Screw Extended System is a medical device manufactured by Syntec Scientific Corporation. It received FDA 510(k) clearance on 2021-09-17 under approval number K202790. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Syntec Orthodontic Mini Screw Extended System?

Syntec Orthodontic Mini Screw Extended System is a medical device that received FDA 510(k) clearance on 2021-09-17. It is manufactured by Syntec Scientific Corporation. The 510(k) number is K202790.

When was Syntec Orthodontic Mini Screw Extended System approved by the FDA?

Syntec Orthodontic Mini Screw Extended System received FDA 510(k) clearance on 2021-09-17, under approval number K202790.

What company makes Syntec Orthodontic Mini Screw Extended System?

Syntec Orthodontic Mini Screw Extended System is manufactured by Syntec Scientific Corporation.

What is the FDA product code for Syntec Orthodontic Mini Screw Extended System?

The FDA product code for Syntec Orthodontic Mini Screw Extended System is OAT.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06885931 Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications) RECRUITING NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05454891 Extended Bolus for Meals in a Closed-loop System COMPLETED NCT05006339 The Use of Remote Monitoring for Orthodontic Retention Review ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 37948287 TCCC Decision Support With Machine Learning Prediction of Hemorrhage Risk, Shock Probability. Military medicine (2023) PMID: 37209414 Adverse events associated with Aveir Journal of cardiovascular electrophysiology (2023) PMID: 30035086 Translational research of one dynamic hip screw system-from the SCI to the FDA. Journal of orthopaedic translation (2016)

Other Devices by Syntec Scientific Corporation

K161327SYNTEC HUMERAL NAIL SYSTEM K191617Syntec Tibial Nail System K181296Syntec Femoral Nail System K202935Syntec Femoral Nail Extended System K200933Syntec Non-Sterile Steinmann Pins System

Related Devices (Code: OAT)

K161197Orthodontic ScrewOsstem Implant Co., Ltd. K152297OBS Anchorage ScrewBomei Co, Ltd. K161335Dual Top Screw SystemJeil Medical Corporation K173623Anchor plateBiomaterials Korea, Inc. K182929BIO-RAY A-1 Anchor Screw SystemMicroware Precision Co., Ltd. K181142Absoanchor MicroimplantDentos, Inc.

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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