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FDA 510(k)

OptiVu™ Shoulder

K-Number: K250108 · 2025-07-09

ApplicantMr Surgical Solutions, LLC
Decision Date2025-07-09
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OptiVu™ Shoulder is the device name listed in this FDA 510(k) record. The listed applicant is Mr Surgical Solutions, LLC. It received FDA 510(k) clearance on 2025-07-09 under 510(k) number K250108. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OptiVu™ Shoulder?

OptiVu™ Shoulder is a medical device that received FDA 510(k) clearance on 2025-07-09. The listed applicant is Mr Surgical Solutions, LLC. The 510(k) number is K250108.

When did OptiVu™ Shoulder receive FDA 510(k) clearance?

OptiVu™ Shoulder received FDA 510(k) clearance on 2025-07-09, under 510(k) number K250108.

Who is the listed applicant for OptiVu™ Shoulder?

The FDA 510(k) record lists Mr Surgical Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OptiVu™ Shoulder?

The FDA product code for OptiVu™ Shoulder is SBF.

Other records listing Mr Surgical Solutions, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252530OptiVu™ ShoulderK252170OptiVu™ Shoulder

Related Devices (Code: SBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261854xvision Spine systemAugmedics, Ltd.K253805Knee+Pixee Medical S.A.S.K252847NextAR Hip PlatformMedacta International S.A.K251639xvision Spine systemAugmedics, Ltd.K252054SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.K252530OptiVu™ ShoulderMr Surgical Solutions, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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