Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Mr Surgical Solutions, LLC. It received FDA 510(k) clearance on 2025-07-09 under approval 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. It is manufactured by Mr Surgical Solutions, LLC. The 510(k) number is K250108.

When was OptiVu™ Shoulder approved by the FDA?

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

What company makes OptiVu™ Shoulder?

OptiVu™ Shoulder is manufactured by Mr Surgical Solutions, LLC.

What is the FDA product code for OptiVu™ Shoulder?

The FDA product code for OptiVu™ Shoulder is SBF.

Other Devices by Mr Surgical Solutions, LLC

K252530OptiVu™ Shoulder K252170OptiVu™ Shoulder

Related Devices (Code: SBF)

K190929xvision Spine system (XVS)Augmedics, Ltd. K202152NextAR TKA PlatformMedacta International S.A. K193559NextAR TKA PlatformMedacta Inernational SA K210859NextAR™ Spine PlatformMedacta International S.A. K211188xvision Spine system (XVS)Augmedics, Ltd. K210153NextAR RSA PlatformMedacta International S.A.

Official Source

View on FDA Database →

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

↑