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FDA 510(k)

Reform® Midline Cortical Screw System

K-Number: K173130 · 2017-12-19

ApplicantPrecision Spine, Inc.
Decision Date2017-12-19
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Reform® Midline Cortical Screw System is a medical device manufactured by Precision Spine, Inc.. It received FDA 510(k) clearance on 2017-12-19 under approval number K173130. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reform® Midline Cortical Screw System?

Reform® Midline Cortical Screw System is a medical device that received FDA 510(k) clearance on 2017-12-19. It is manufactured by Precision Spine, Inc.. The 510(k) number is K173130.

When was Reform® Midline Cortical Screw System approved by the FDA?

Reform® Midline Cortical Screw System received FDA 510(k) clearance on 2017-12-19, under approval number K173130.

What company makes Reform® Midline Cortical Screw System?

Reform® Midline Cortical Screw System is manufactured by Precision Spine, Inc..

What is the FDA product code for Reform® Midline Cortical Screw System?

The FDA product code for Reform® Midline Cortical Screw System is NKB.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED NCT07594483 Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07277803 Device-Based vs Manual Sensory Training in Low Back Pain NOT_YET_RECRUITING NCT04043910 Functional Near Infra-Red Spectroscopic Study of Central Auditory System Cortical Functional Reorganization COMPLETED

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: 37209414 Adverse events associated with Aveir Journal of cardiovascular electrophysiology (2023) PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022) PMID: 29082710 [How to adapt to the requirements of "clinical value-oriented drug innovation" for pharmaceutical research in application process of new traditional Chinese medicine]. Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica (2017)

Other Devices by Precision Spine, Inc.

K161809ShurFit CpTi-HA ACIF Interbody Fusion System K162211AccuFit Lateral Plate System K162300Reform® POCT System K160568Precision Spine Interspinous Plate System K171657ShurFit 2C Lumbar Interbody Fusion System K172495Reform® POCT System

View all 17 devices →

Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, 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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