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Surgical Theater Inc

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
8
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0321-2026Class IISurgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaSeptember 16, 2025
Z-0323-2026Class IIEndo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.September 16, 2025
Z-0319-2026Class IISuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological systemSeptember 16, 2025
Z-0325-2026Class IISurgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented realitySeptember 16, 2025
Z-0322-2026Class IISyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.September 16, 2025
Z-0320-2026Class IISurgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiolSeptember 16, 2025
Z-0324-2026Class IISpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPRSeptember 16, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K252054SpineAR SNAP (SyncAR Spine)September 29, 2025
K243623SpineAR SNAP (SyncAR Spine)December 24, 2024
K213034SpineAR SNAPSeptember 29, 2022
K201465SuRgical Planner (SRP) BrainStormJuly 17, 2020
K170793SuRgical Planner (SRP)February 12, 2018
K160584Surgical Navigation Advanced Platform (SNAP)June 28, 2016
K140819SURGICAL NAVIGATION ADVANCED PLATFORMJune 27, 2014
K123023SURGERY REHEARSAL PLATFORMFebruary 8, 2013