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FDA 510(k)

ROSA® Shoulder System

K-Number: K233199 · 2024-02-21

ApplicantOrthosoft Inc (D/B/A Zimmer Cas)
Decision Date2024-02-21
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ROSA® Shoulder System is a medical device manufactured by Orthosoft Inc (D/B/A Zimmer Cas). It received FDA 510(k) clearance on 2024-02-21 under approval number K233199. 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® Shoulder System?

ROSA® Shoulder System is a medical device that received FDA 510(k) clearance on 2024-02-21. It is manufactured by Orthosoft Inc (D/B/A Zimmer Cas). The 510(k) number is K233199.

When was ROSA® Shoulder System approved by the FDA?

ROSA® Shoulder System received FDA 510(k) clearance on 2024-02-21, under approval number K233199.

What company makes ROSA® Shoulder System?

ROSA® Shoulder System is manufactured by Orthosoft Inc (D/B/A Zimmer Cas).

What is the FDA product code for ROSA® Shoulder System?

The FDA product code for ROSA® Shoulder System is OLO.

Related Clinical Trials

NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT05951491 Improving Arm Function Using Wearable Exoskeletons SUSPENDED NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT01480440 Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System ACTIVE_NOT_RECRUITING NCT07550543 PEMF Therapy in Shoulder Tendinopathy RECRUITING NCT07421245 OsseoFit Stemless Shoulder System (Anatomic) NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

Other Devices by Orthosoft Inc (D/B/A Zimmer Cas)

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Related Devices (Code: OLO)

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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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