OptiVu Shoulder— 510(k) K252530

Substantially Equivalent

Mr Surgical Solutions, LLC

FDA 510(k) clearance K252530 for OptiVu Shoulder, Substantially Equivalent on 2025-09-10. Applicant: Mr Surgical Solutions, LLC. Device class: 2.

Clearance details

Applicant: Mr Surgical Solutions, LLC
Product code: Code SBF
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2025-08-11
Decision date: 2025-09-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Conshohocken, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code SBF

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K252847 — NextAR Hip Platform2026-01-09
K251639 — xvision Spine system2025-10-03
K252054 — SpineAR SNAP (SyncAR Spine)2025-09-29

More clearances from Mr Surgical Solutions, LLC

K252170 — OptiVu Shoulder2025-08-08
K250108 — OptiVu Shoulder2025-07-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.