FDA-Device2025-11-05Class II
SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality
Surgical Theater Inc
Hazard
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
Sold states
Worldwide - US Nationwide distribution in the states of MI, FL, DC, MN, CA, TX, NJ, PA, AZ, NY, KY, IN, WV and the countries of Italy, Germany, Israel, UK.
Affected count
3 units
Manufactured in
23645 Mercantile Rd Ste M, N/A, Beachwood, OH, United States
Products
SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0324-2026Don't want to check this manually?
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