FDA 510(k) K233199, ROSA® Shoulder System, by Orthosoft Inc (D/B/A Zimmer Cas)
FDA 510(k) K233199, ROSA® Shoulder System, by Orthosoft Inc (D/B/A Zimmer Cas)
Device Classification Name: Orthopedic Stereotaxic Instrument
510(k) Number: K233199
Device Name: ROSA® Shoulder System
Applicant: Orthosoft Inc (D/B/A Zimmer Cas)
Regulation Number: 882.4560
Classification Product Code: OLO
Date Received: 09/28/2023
Decision Date: 02/21/2024
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
510k Review Panel: Orthopedic
Total number of pages: 8,910
Fully redacted pages: 8,495
Content pages: 415
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