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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 a medical device manufactured by Surgical Theater, Inc.. It received FDA 510(k) clearance on 2022-09-29 under approval 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. It is manufactured by Surgical Theater, Inc.. The 510(k) number is K213034.

When was SpineAR SNAP approved by the FDA?

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

What company makes SpineAR SNAP?

SpineAR SNAP is manufactured by Surgical Theater, Inc..

What is the FDA product code for SpineAR SNAP?

The FDA product code for SpineAR SNAP is SBF.

Other Devices by Surgical Theater, Inc.

K201465SuRgical Planner (SRP) BrainStorm K243623SpineAR SNAP (SyncAR Spine) K252054SpineAR SNAP (SyncAR Spine)

Related Devices (Code: SBF)

K190929xvision Spine system (XVS)Augmedics, Ltd. K202152NextAR TKA PlatformMedacta International S.A. K193559NextAR TKA PlatformMedacta Inernational SA K210859NextAR™ Spine PlatformMedacta International S.A. K211188xvision Spine system (XVS)Augmedics, Ltd. K210153NextAR RSA PlatformMedacta International S.A.

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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