Surgical Navigation Advanced Platform (SNAP)— 510(k) K160584
Substantially EquivalentSurgical Theater, LLC
FDA 510(k) clearance K160584 for Surgical Navigation Advanced Platform (SNAP), Substantially Equivalent on 2016-06-28. Applicant: Surgical Theater, LLC. Device class: 2.
Clearance details
- Applicant
- Surgical Theater, LLC
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mayfield Village, OH, US
Recent devices under product code LLZ
view allMore clearances from Surgical Theater, LLC
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K160584
K-number listed on FDA's recall record- Z-0320-2026 — Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
- Z-0321-2026 — Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system
- Z-0322-2026 — SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system
- Z-0323-2026 — Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological system
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160584.
Data sourced from openFDA. This site is unofficial and independent of the FDA.