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FDA 510(k)

SpineAR SNAP (SyncAR Spine)

K-Number: K252054 · 2025-09-29

ApplicantSurgical Theater, Inc.
Decision Date2025-09-29
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SpineAR SNAP (SyncAR Spine) 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 2025-09-29 under 510(k) number K252054. 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 (SyncAR Spine)?

SpineAR SNAP (SyncAR Spine) is a medical device that received FDA 510(k) clearance on 2025-09-29. The listed applicant is Surgical Theater, Inc.. The 510(k) number is K252054.

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

SpineAR SNAP (SyncAR Spine) received FDA 510(k) clearance on 2025-09-29, under 510(k) number K252054.

Who is the listed applicant for SpineAR SNAP (SyncAR Spine)?

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 (SyncAR Spine)?

The FDA product code for SpineAR SNAP (SyncAR Spine) 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.

K243623SpineAR SNAP (SyncAR Spine)K213034SpineAR SNAPK201465SuRgical 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.K252530OptiVu™ ShoulderMr Surgical Solutions, LLCK251737NextAR(TM) Shoulder 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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