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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 the device name listed in this FDA 510(k) record. The listed applicant is Spinal Elements, Inc.. It received FDA 510(k) clearance on 2019-04-03 under 510(k) 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. The listed applicant is Spinal Elements, Inc.. The 510(k) number is K190289.

When did Karma® Fixation System receive FDA 510(k) clearance?

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

Who is the listed applicant for Karma® Fixation System?

The FDA 510(k) record lists Spinal Elements, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Spinal Elements, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: OWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261374LigaPASS™ SystemMedicrea International S.A.SK253615Invictus Bands SystemAlphatec Spine, Inc.K222097OLYMPIC Deformity Band SystemAstura MedicalK230565HILINE™ Fixation SystemGlobus Medical, Inc.K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SAK211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, 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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