FDA 510(k) clearance · back to tracker

ROSA Knee System with UltraSound Imaging Platform (USIP)

Balmoral Medical, LLC cleared K252058 on 2026-02-06, decision: substantially equivalent

K-number

K252058

Sponsor

Balmoral Medical, LLC

Device

ROSA Knee System with UltraSound Imaging Platform (USIP)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-02-06

Product code

OLO

Advisory committee

Neurology

Medical specialty

Neurology

Regulation number

882.4560

Official FDA record

Open K252058on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.