Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Surgical Theater with 8 510(k) clearances, 7 device recalls and 1 AI-enabled device. The most recent is a 510(k) clearance dated Sep 29, 2025: SpineAR SNAP (SyncAR Spine).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 29, 2025 | SpineAR SNAP (SyncAR Spine)K252054 · SBF | 510(k) clearances |
| Sep 29, 2025 | SpineAR SNAP (SyncAR Spine)K252054 · Neurology | AI-enabled devices |
| Sep 16, 2025 | SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological systemClass II · A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may | Device recalls |
| Sep 16, 2025 | Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented realityClass II · A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may | Device recalls |
| Sep 16, 2025 | Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological systeClass II · A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may | Device recalls |
| Sep 16, 2025 | SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented realityClass II · A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may | Device recalls |
| Sep 16, 2025 | Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological systemClass II · A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may | Device recalls |
| Sep 16, 2025 | Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological systemClass II · A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may | Device recalls |
| Sep 16, 2025 | SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological Class II · A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may | Device recalls |
| Dec 24, 2024 | SpineAR SNAP (SyncAR Spine)K243623 · SBF | 510(k) clearances |
| Sep 29, 2022 | SpineAR SNAPK213034 · SBF | 510(k) clearances |
| Jul 17, 2020 | SuRgical Planner (SRP) BrainStormK201465 · LLZ | 510(k) clearances |
| Feb 12, 2018 | SuRgical Planner (SRP)K170793 · LLZ | 510(k) clearances |
| Jun 28, 2016 | Surgical Navigation Advanced Platform (SNAP)K160584 · LLZ | 510(k) clearances |
| Jun 27, 2014 | SURGICAL NAVIGATION ADVANCED PLATFORMK140819 · LLZ | 510(k) clearances |
| Feb 8, 2013 | SURGERY REHEARSAL PLATFORMK123023 · LLZ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
