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)

Precision Spine Navigation Instrumentation

K-Number: K181606 · 2019-09-27

ApplicantPrecision Spine, Inc.
Decision Date2019-09-27
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Precision Spine Navigation Instrumentation is a medical device manufactured by Precision Spine, Inc.. It received FDA 510(k) clearance on 2019-09-27 under approval number K181606. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Precision Spine Navigation Instrumentation?

Precision Spine Navigation Instrumentation is a medical device that received FDA 510(k) clearance on 2019-09-27. It is manufactured by Precision Spine, Inc.. The 510(k) number is K181606.

When was Precision Spine Navigation Instrumentation approved by the FDA?

Precision Spine Navigation Instrumentation received FDA 510(k) clearance on 2019-09-27, under approval number K181606.

What company makes Precision Spine Navigation Instrumentation?

Precision Spine Navigation Instrumentation is manufactured by Precision Spine, Inc..

What is the FDA product code for Precision Spine Navigation Instrumentation?

The FDA product code for Precision Spine Navigation Instrumentation is OLO.

Related Clinical Trials

NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT07516145 Robotic Transjugular Transcatheter Tricuspid Valve Replacement RECRUITING

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 K173130Reform® Midline Cortical Screw System K171657ShurFit 2C Lumbar Interbody Fusion System

View all 17 devices →

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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.

↑