Surgical Theater Inc
Beachwood, OH, US
SURGICAL THEATER, INC. appears in FDA device records in Beachwood, OH. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Surgical Theater Inc between 2013 and 2025. The busiest year on record is 2013, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252054 | SpineAR SNAP (SyncAR Spine) | SBF | Substantially Equivalent | |
| K243623 | SpineAR SNAP (SyncAR Spine) | SBF | Substantially Equivalent | |
| K213034 | SpineAR SNAP | SBF | Substantially Equivalent | |
| K201465 | SuRgical Planner (SRP) BrainStorm | LLZ | Substantially Equivalent | |
| K170793 | SuRgical Planner (SRP) | LLZ | Substantially Equivalent | |
| K160584 | Surgical Navigation Advanced Platform (SNAP) | LLZ | Substantially Equivalent | |
| K140819 | SURGICAL NAVIGATION ADVANCED PLATFORM | LLZ | Substantially Equivalent | |
| K123023 | SURGERY REHEARSAL PLATFORM | LLZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010197287 | 3010197287 | SURGICAL THEATER, INC. | 23645 Mercantile Road, Beachwood, OH 44122 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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 image layer(s) to the primary image layer. | Class II | Completed | |
| Z-0324-2026 | SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, 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 image layer(s) to the primary image layer. | Class II | Completed | |
| Z-0323-2026 | Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, 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 image layer(s) to the primary image layer. | Class II | Completed | |
| Z-0322-2026 | SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, 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 image layer(s) to the primary image layer. | Class II | Completed | |
| Z-0321-2026 | Surgical Navigation Advanced Platform Patient Engagement (PE 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 image layer(s) to the primary image layer. | Class II | Completed | |
| 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 image layer(s) to the primary image layer. | Class II | Completed | |
| 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 image layer(s) to the primary image layer. | Class II | Completed |
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Data as of , FDA export datePage updated Source: openFDA, public domain