Chrysalis Intelligence · Sponsors · Surgical Theater, Inc.

Surgical Theater, Inc.

Mayfield Village, OH, US · 4 510(k) clearances · 7 recalls

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Total clearances
4
2020-07-17 → 2025-09-29
Last 12 months
1
Product codes
2
Most recent
2025-09-29
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
SBF Orthopedic Augmented Reality Class II Neurology 3 2025-09-29
LLZ System, Image Processing, Radiological Class II Radiology 1 2020-07-17
Safety

Recalls (7)

Class I (serious)
0
Risk of injury / death
Total recalls
7
Currently ongoing
7
Most recent
2025-09-16
DateSeverityStatusRecall # ProductCodeReason
2025-09-16 Class II Ongoing Z-0325-2026 Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality — A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary i…
2025-09-16 Class II Ongoing Z-0324-2026 SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic a… — A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary i…
2025-09-16 Class II Ongoing Z-0323-2026 Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processin… — A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary i…
2025-09-16 Class II Ongoing Z-0322-2026 SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging proc… — A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary i…
2025-09-16 Class II Ongoing Z-0321-2026 Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radi… — A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary i…
2025-09-16 Class II Ongoing Z-0320-2026 Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system — A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary i…
2025-09-16 Class II Ongoing Z-0319-2026 SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system — A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary i…
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2025-09-29 K252054 SpineAR SNAP (SyncAR Spine) SBF Class II Neurology
2024-12-24 K243623 SpineAR SNAP (SyncAR Spine) SBF Class II Neurology
2022-09-29 K213034 SpineAR SNAP SBF Class II Neurology
2020-07-17 K201465 SuRgical Planner (SRP) BrainStorm LLZ Class II Radiology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence