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FDA 510(k)

Spinal Elements Cerclage System

K-Number: K180728 · 2018-09-06

ApplicantSpinal Elements, Inc.
Decision Date2018-09-06
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Spinal Elements Cerclage System is a medical device manufactured by Spinal Elements, Inc.. It received FDA 510(k) clearance on 2018-09-06 under approval number K180728. 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 Spinal Elements Cerclage System?

Spinal Elements Cerclage System is a medical device that received FDA 510(k) clearance on 2018-09-06. It is manufactured by Spinal Elements, Inc.. The 510(k) number is K180728.

When was Spinal Elements Cerclage System approved by the FDA?

Spinal Elements Cerclage System received FDA 510(k) clearance on 2018-09-06, under approval number K180728.

What company makes Spinal Elements Cerclage System?

Spinal Elements Cerclage System is manufactured by Spinal Elements, Inc..

What is the FDA product code for Spinal Elements Cerclage System?

The FDA product code for Spinal Elements Cerclage System is OWI.

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Related PubMed Literature

PMID: 41987831 From Concept to Clinic: Pre-Clinical Testing and Regulatory Considerations in Spine Implant Development. JOR spine (2026) 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 Spinal Elements, Inc.

K153352Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System K160465Spinal Elements' Spinous Process Plate System K152011Lucent Intervertebral Body Fusion Device K170235Lucent® K182584Lucent® XP K181837Spinal Elements Ti-Bond coated devices

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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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