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FDA 510(k)

ROSA Knee System with UltraSound Imaging Platform (USIP)

K-Number: K252058 · 2026-02-06

ApplicantBalmoral Medical, LLC
Decision Date2026-02-06
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ROSA Knee System with UltraSound Imaging Platform (USIP) is the device name listed in this FDA 510(k) record. The listed applicant is Balmoral Medical, LLC. It received FDA 510(k) clearance on 2026-02-06 under 510(k) number K252058. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROSA Knee System with UltraSound Imaging Platform (USIP)?

ROSA Knee System with UltraSound Imaging Platform (USIP) is a medical device that received FDA 510(k) clearance on 2026-02-06. The listed applicant is Balmoral Medical, LLC. The 510(k) number is K252058.

When did ROSA Knee System with UltraSound Imaging Platform (USIP) receive FDA 510(k) clearance?

ROSA Knee System with UltraSound Imaging Platform (USIP) received FDA 510(k) clearance on 2026-02-06, under 510(k) number K252058.

Who is the listed applicant for ROSA Knee System with UltraSound Imaging Platform (USIP)?

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

What is the FDA product code for ROSA Knee System with UltraSound Imaging Platform (USIP)?

The FDA product code for ROSA Knee System with UltraSound Imaging Platform (USIP) is OLO.

Related Clinical Trials

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.

NCT06134167Transdermal Compress IDE StudyRECRUITINGNCT06089291Persona IQ Cohort StudyACTIVE_NOT_RECRUITINGNCT06222931Effects of Whole Body Vibration in Different Devices on Bone and Muscle Mass in Postmenopausal WomenCOMPLETED

Related Devices (Code: OLO)

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.

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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.

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