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FDA 510(k)

ARAI Surgical Navigation System

K-Number: K211254 · 2022-01-14

ApplicantSurgalign Spine Technologies
Decision Date2022-01-14
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ARAI Surgical Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Surgalign Spine Technologies. It received FDA 510(k) clearance on 2022-01-14 under 510(k) number K211254. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARAI Surgical Navigation System?

ARAI Surgical Navigation System is a medical device that received FDA 510(k) clearance on 2022-01-14. The listed applicant is Surgalign Spine Technologies. The 510(k) number is K211254.

When did ARAI Surgical Navigation System receive FDA 510(k) clearance?

ARAI Surgical Navigation System received FDA 510(k) clearance on 2022-01-14, under 510(k) number K211254.

Who is the listed applicant for ARAI Surgical Navigation System?

The FDA 510(k) record lists Surgalign Spine Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARAI Surgical Navigation System?

The FDA product code for ARAI Surgical Navigation System is SBF.

Other records listing Surgalign Spine Technologies 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.

K231611HOLO Portal™ Surgical Guidance SystemK221403Cortera Spinal Fixation System

Related Devices (Code: SBF)

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.

K261854xvision Spine systemAugmedics, Ltd.K253805Knee+Pixee Medical S.A.S.K252847NextAR Hip PlatformMedacta International S.A.K251639xvision Spine systemAugmedics, Ltd.K252054SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.K252530OptiVu™ ShoulderMr Surgical Solutions, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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