Surgical Theater Inc
FDA Regulatory Profile
Surgical Theater Inc appears in FDA public data with 7 recalls, 8 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0319-2026, Class II) was initiated on September 16, 2025. Its most recent 510(k) clearance was granted on September 29, 2025.
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 8
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0319-2026 | Class II | SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system | September 16, 2025 |
| Z-0325-2026 | Class II | Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality | September 16, 2025 |
| Z-0322-2026 | Class II | SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP. | September 16, 2025 |
| Z-0320-2026 | Class II | Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiol | September 16, 2025 |
| Z-0321-2026 | Class II | Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, ima | September 16, 2025 |
| Z-0323-2026 | Class II | Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12. | September 16, 2025 |
| Z-0324-2026 | Class II | SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR | September 16, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252054 | SpineAR SNAP (SyncAR Spine) | September 29, 2025 |
| K243623 | SpineAR SNAP (SyncAR Spine) | December 24, 2024 |
| K213034 | SpineAR SNAP | September 29, 2022 |
| K201465 | SuRgical Planner (SRP) BrainStorm | July 17, 2020 |
| K170793 | SuRgical Planner (SRP) | February 12, 2018 |
| K160584 | Surgical Navigation Advanced Platform (SNAP) | June 28, 2016 |
| K140819 | SURGICAL NAVIGATION ADVANCED PLATFORM | June 27, 2014 |
| K123023 | SURGERY REHEARSAL PLATFORM | February 8, 2013 |