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FDA 510(k)

Karma® Fixation System

K-Number: K190289 · 2019-04-03

ApplicantSpinal Elements, Inc.
Decision Date2019-04-03
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Karma® Fixation System is a medical device manufactured by Spinal Elements, Inc.. It received FDA 510(k) clearance on 2019-04-03 under approval number K190289. 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 Karma® Fixation System?

Karma® Fixation System is a medical device that received FDA 510(k) clearance on 2019-04-03. It is manufactured by Spinal Elements, Inc.. The 510(k) number is K190289.

When was Karma® Fixation System approved by the FDA?

Karma® Fixation System received FDA 510(k) clearance on 2019-04-03, under approval number K190289.

What company makes Karma® Fixation System?

Karma® Fixation System is manufactured by Spinal Elements, Inc..

What is the FDA product code for Karma® Fixation System?

The FDA product code for Karma® Fixation System is OWI.

Related Clinical Trials

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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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