Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgical Theater, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252054 | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | 2025-09-29 | 90 | 0 |
| K243623 | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | 2024-12-24 | 29 | 1 |
| K213034 | SpineAR SNAP | Surgical Theater, Inc. | 2022-09-29 | 373 | 0 |
| K201465 | SuRgical Planner (SRP) BrainStorm | Surgical Theater, Inc. | 2020-07-17 | 45 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda