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FDA 510(k)

Rosa Knee System

K-Number: K230180 · 2023-02-22

ApplicantOrthosoft Inc (D/B/A Zimmer Cas)
Decision Date2023-02-22
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Rosa Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Orthosoft Inc (D/B/A Zimmer Cas). It received FDA 510(k) clearance on 2023-02-22 under 510(k) number K230180. 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?

Rosa Knee System is a medical device that received FDA 510(k) clearance on 2023-02-22. The listed applicant is Orthosoft Inc (D/B/A Zimmer Cas). The 510(k) number is K230180.

When did Rosa Knee System receive FDA 510(k) clearance?

Rosa Knee System received FDA 510(k) clearance on 2023-02-22, under 510(k) number K230180.

Who is the listed applicant for Rosa Knee System?

The FDA 510(k) record lists Orthosoft Inc (D/B/A Zimmer Cas) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rosa Knee System?

The FDA product code for Rosa Knee System 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.

NCT05391828Persona MC vs PS RCT With ROSARECRUITINGNCT05966519ROSA Knee Intraoperative Planning Flexibility StudyRECRUITING

Other records listing Orthosoft Inc (D/B/A Zimmer Cas) as applicant

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.

K261510Signature™ ONE SystemK260582ROSA® Shoulder SystemK260104Signature™ ONE SystemK251314Rosa® Knee SystemK242864ROSA® Knee SystemK233199ROSA® Shoulder System

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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.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

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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