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FDA 510(k)

ROSA® Knee System

K-Number: K213708 · 2022-04-22

ApplicantOrthosoft Inc (D/B/A Zimmer Cas)
Decision Date2022-04-22
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 2022-04-22 under 510(k) number K213708. 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 2022-04-22. The listed applicant is Orthosoft Inc (D/B/A Zimmer Cas). The 510(k) number is K213708.

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

ROSA® Knee System received FDA 510(k) clearance on 2022-04-22, under 510(k) number K213708.

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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