Company ยท US
Surgical Theater Inc
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2025. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 29, 2025 | K252054 | SpineAR SNAP (SyncAR Spine) Surgical Theater, Inc. | SBF |
| Dec 24, 2024 | K243623 | SpineAR SNAP (SyncAR Spine) Surgical Theater, Inc. | SBF |
| Sep 29, 2022 | K213034 | SpineAR SNAP Surgical Theater, Inc. | SBF |
| Jul 17, 2020 | K201465 | SuRgical Planner (SRP) BrainStorm Surgical Theater, Inc. | LLZ |
| Feb 12, 2018 | K170793 | SuRgical Planner (SRP) Surgical Theater, LLC | LLZ |
| Jun 28, 2016 | K160584 | Surgical Navigation Advanced Platform (SNAP) Surgical Theater, LLC | LLZ |
| Jun 27, 2014 | K140819 | SURGICAL NAVIGATION ADVANCED PLATFORM Surgical Theater, LLC | LLZ |
| Feb 8, 2013 | K123023 | SURGERY REHEARSAL PLATFORM Surgical Theater, LLC | LLZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2025 | Surgical Theater Inc Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality Terminated |
LLZ | K201465 |
| Oct 24, 2025 | Surgical Theater Inc SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality Terminated |
SFB | K243623 |
| Oct 24, 2025 | Surgical Theater Inc Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological system Terminated |
LLZ | K160584 |
| Oct 24, 2025 | Surgical Theater Inc SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system Terminated |
LLZ | K160584 |
| Oct 24, 2025 | Surgical Theater Inc Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system Terminated |
LLZ | K160584 |
| Oct 24, 2025 | Surgical Theater Inc Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system Terminated |
LLZ | K160584 |
| Oct 24, 2025 | Surgical Theater Inc SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system Terminated |
LLZ | K170793 |