Data / Medical devices / United States / Surgical Theater, Inc.
Surgical Theater, Inc.: FDA-registered device maker in Beachwood, OH, United States, 5 510(k) clearances
Surgical Theater, Inc. is registered with the FDA (registration 3010197287) in Beachwood, OH, United States. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 29, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010197287
- Address
- 23645 Mercantile Road Suite M, Beachwood, OH, United States, 44122
- Owner or operator
- Surgical Theater, Inc. (10044065)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- July 12, 2016
- Registered through
- 2026
- Brand names listed
- BrainStorm, Endo SNAP, PE SNAP, PlanXR, SpineAR SNAP, SuRgical Planner (SRP), Surgical Navigation Advanced Platform (SNAP), SyncAR Cranial and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Augmented Reality | SBF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 29, 2025 | K252054 | SpineAR SNAP (SyncAR Spine) | SBF | Substantially Equivalent | Surgical Theater, Inc. | accessdata.fda.gov |
| December 24, 2024 | K243623 | SpineAR SNAP (SyncAR Spine) | SBF | Substantially Equivalent | Surgical Theater, Inc. | accessdata.fda.gov |
| July 17, 2020 | K201465 | SuRgical Planner (SRP) BrainStorm | LLZ | Substantially Equivalent | Surgical Theater, Inc. | accessdata.fda.gov |
| February 12, 2018 | K170793 | SuRgical Planner (SRP) | LLZ | Substantially Equivalent | Surgical Theater, LLC | accessdata.fda.gov |
| June 28, 2016 | K160584 | Surgical Navigation Advanced Platform (SNAP) | LLZ | Substantially Equivalent | Surgical Theater, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 16, 2025 | 97715 | Class II | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
Updated October 24, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.