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)

Spineology Navigation Instruments

K-Number: K182345 · 2018-09-21

ApplicantSpineology, Inc.
Decision Date2018-09-21
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Spineology Navigation Instruments is a medical device manufactured by Spineology, Inc.. It received FDA 510(k) clearance on 2018-09-21 under approval number K182345. 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 Spineology Navigation Instruments?

Spineology Navigation Instruments is a medical device that received FDA 510(k) clearance on 2018-09-21. It is manufactured by Spineology, Inc.. The 510(k) number is K182345.

When was Spineology Navigation Instruments approved by the FDA?

Spineology Navigation Instruments received FDA 510(k) clearance on 2018-09-21, under approval number K182345.

What company makes Spineology Navigation Instruments?

Spineology Navigation Instruments is manufactured by Spineology, Inc..

What is the FDA product code for Spineology Navigation Instruments?

The FDA product code for Spineology Navigation Instruments is OLO.

Related Clinical Trials

NCT07518615 Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon RECRUITING

Other Devices by Spineology, Inc.

K160074Rampart D Lumbar Interbody Fusion Device K161694Threshold™ Pedicular Fixation System K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation System K153323Palisade Pedicular Fixation System K153082Rampart A Lumbar Interbody Fusion Device

View all 33 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.

↑