# Surgical Theater, LLC

- Location (FDA's records): Mayfield Village, OH
- FDA decisions: 8 (2013–2025): 8 510(k) clearances
- Names in FDA's records: Surgical Theater, LLC (4); Surgical Theater, Inc. (4)
- Product codes: LLZ (5), SBF (3)
- 510(k) review time since 2016: median 105 days, against 98 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 8 (6 its own); citations of its devices by later devices: 10 (6 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Simbionix, Ltd.: 1 (https://510kreport.com/company/simbionix)
- Medtronic Navigation, Inc.: 1 (https://510kreport.com/company/medtronic-navigation)

## Firms that cite its devices most
- Immersivetouch: 1 (https://510kreport.com/company/immersivetouch)
- Echopixel, Inc.: 1 (https://510kreport.com/company/echopixel)
- Cascination AG: 1 (https://510kreport.com/company/cascination)
- Precisionos Technology, Inc.: 1 (https://510kreport.com/company/precisionos-technology)

## Its most-cited devices
- K123023: Surgery Rehearsal Platform (2013), cited by 4
- K201465: SuRgical Planner (SRP) BrainStorm (2020), cited by 2
- K140819: Surgical Navigation Advanced Platform (2014), cited by 1
- K170793: SuRgical Planner (SRP) (2018), cited by 1
- K213034: SpineAR SNAP (2022), cited by 1
- K243623: SpineAR SNAP (SyncAR Spine) (2024), cited by 1

## Recent decisions
- K252054: SpineAR SNAP (SyncAR Spine) (Sep 29, 2025)
- K243623: SpineAR SNAP (SyncAR Spine) (Dec 24, 2024)
- K213034: SpineAR SNAP (Sep 29, 2022)
- K201465: SuRgical Planner (SRP) BrainStorm (Jul 17, 2020)
- K170793: SuRgical Planner (SRP) (Feb 12, 2018)
- K160584: Surgical Navigation Advanced Platform (SNAP) (Jun 28, 2016)
- K140819: Surgical Navigation Advanced Platform (Jun 27, 2014)
- K123023: Surgery Rehearsal Platform (Feb 8, 2013)

Source page: https://510kreport.com/company/surgical-theater