Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgical Theater, LLC — 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) |
|---|---|---|---|---|---|
| K170793 | SuRgical Planner (SRP) | Surgical Theater, LLC | 2018-02-12 | 333 | 1 |
| K160584 | Surgical Navigation Advanced Platform (SNAP) | Surgical Theater, LLC | 2016-06-28 | 119 | 4 |
| K140819 | SURGICAL NAVIGATION ADVANCED PLATFORM | Surgical Theater, LLC | 2014-06-27 | 87 | 0 |
| K123023 | SURGERY REHEARSAL PLATFORM | Surgical Theater, LLC | 2013-02-08 | 133 | 0 |
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