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FDA 510(k)

SpineAR SNAP

K-Number: K213034 · 2022-09-29

ApplicantSurgical Theater, Inc.
Decision Date2022-09-29
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SpineAR SNAP is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Theater, Inc.. It received FDA 510(k) clearance on 2022-09-29 under 510(k) number K213034. 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 SpineAR SNAP?

SpineAR SNAP is a medical device that received FDA 510(k) clearance on 2022-09-29. The listed applicant is Surgical Theater, Inc.. The 510(k) number is K213034.

When did SpineAR SNAP receive FDA 510(k) clearance?

SpineAR SNAP received FDA 510(k) clearance on 2022-09-29, under 510(k) number K213034.

Who is the listed applicant for SpineAR SNAP?

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

What is the FDA product code for SpineAR SNAP?

The FDA product code for SpineAR SNAP is SBF.

Other records listing Surgical Theater, 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.

K252054SpineAR SNAP (SyncAR Spine)K243623SpineAR SNAP (SyncAR Spine)K201465SuRgical Planner (SRP) BrainStormK170793SuRgical Planner (SRP)K160584Surgical Navigation Advanced Platform (SNAP)

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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