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FDA 510(k)

Precision Spine Interspinous Plate System

K-Number: K160568 · 2016-05-04

ApplicantPrecision Spine, Inc.
Decision Date2016-05-04
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Precision Spine Interspinous Plate System is a medical device manufactured by Precision Spine, Inc.. It received FDA 510(k) clearance on 2016-05-04 under approval number K160568. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Precision Spine Interspinous Plate System?

Precision Spine Interspinous Plate System is a medical device that received FDA 510(k) clearance on 2016-05-04. It is manufactured by Precision Spine, Inc.. The 510(k) number is K160568.

When was Precision Spine Interspinous Plate System approved by the FDA?

Precision Spine Interspinous Plate System received FDA 510(k) clearance on 2016-05-04, under approval number K160568.

What company makes Precision Spine Interspinous Plate System?

Precision Spine Interspinous Plate System is manufactured by Precision Spine, Inc..

What is the FDA product code for Precision Spine Interspinous Plate System?

The FDA product code for Precision Spine Interspinous Plate System is PEK.

Related Clinical Trials

NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07580651 Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring NOT_YET_RECRUITING NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED

Related PubMed Literature

PMID: 36074993 Reported Events Associated With Spine Robots: An Analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database. Global spine journal (2023)

Other Devices by Precision Spine, Inc.

K161809ShurFit CpTi-HA ACIF Interbody Fusion System K162211AccuFit Lateral Plate System K162300Reform® POCT System K173130Reform® Midline Cortical Screw System K171657ShurFit 2C Lumbar Interbody Fusion System K172495Reform® POCT System

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Related Devices (Code: PEK)

K161016Z-Clamp ISP SystemZavation, LLC K153302coflex-IFParadigm Spine, LLC K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc. K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC K162849Huvex Interspinous Fixation SystemDio Medical Co., Ltd. K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity

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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