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FDA 510(k)

The Gecko Spinal System

K-Number: K200281 · 2020-03-31

ApplicantOrtho Development Corporation
Decision Date2020-03-31
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The Gecko Spinal System is a medical device manufactured by Ortho Development Corporation. It received FDA 510(k) clearance on 2020-03-31 under approval number K200281. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The Gecko Spinal System?

The Gecko Spinal System is a medical device that received FDA 510(k) clearance on 2020-03-31. It is manufactured by Ortho Development Corporation. The 510(k) number is K200281.

When was The Gecko Spinal System approved by the FDA?

The Gecko Spinal System received FDA 510(k) clearance on 2020-03-31, under approval number K200281.

What company makes The Gecko Spinal System?

The Gecko Spinal System is manufactured by Ortho Development Corporation.

What is the FDA product code for The Gecko Spinal System?

The FDA product code for The Gecko Spinal System is OWI.

Related Clinical Trials

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Ortho Development Corporation

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Related Devices (Code: OWI)

K160698LigaPASSMedicrea International SA K161267Response BandLoc Spinal FixationOrthoPediatrics Corp. K161265NuVasive® VersaTie SystemNu Vasive, Incorporated K153348JAZZ LOCKImplanet, S.A. K160208NILE Alternative Fixation Spinal SystemK2m, Inc. K173117NuVasive® VersaTie™ SystemNuvasive, 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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