SpineAR SNAP (SyncAR Spine)
K-Number: K243623 · 2024-12-24
ApplicantSurgical Theater, Inc.
Decision Date2024-12-24
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
SpineAR SNAP (SyncAR Spine) is a medical device manufactured by Surgical Theater, Inc.. It received FDA 510(k) clearance on 2024-12-24 under approval number K243623. 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 2024-12-24. It is manufactured by Surgical Theater, Inc.. The 510(k) number is K243623.
When was SpineAR SNAP (SyncAR Spine) approved by the FDA?
SpineAR SNAP (SyncAR Spine) received FDA 510(k) clearance on 2024-12-24, under approval number K243623.
What company makes SpineAR SNAP (SyncAR Spine)?
SpineAR SNAP (SyncAR Spine) is manufactured by Surgical Theater, Inc..
What is the FDA product code for SpineAR SNAP (SyncAR Spine)?
The FDA product code for SpineAR SNAP (SyncAR Spine) is SBF.
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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.