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FDA 510(k)

iASSIST Knee System

K-Number: K213033 · 2022-01-14

ApplicantOrthosoft D/B/A Zimmer Cas
Decision Date2022-01-14
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

iASSIST Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Orthosoft D/B/A Zimmer Cas. It received FDA 510(k) clearance on 2022-01-14 under 510(k) number K213033. 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 iASSIST Knee System?

iASSIST Knee System is a medical device that received FDA 510(k) clearance on 2022-01-14. The listed applicant is Orthosoft D/B/A Zimmer Cas. The 510(k) number is K213033.

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

iASSIST Knee System received FDA 510(k) clearance on 2022-01-14, under 510(k) number K213033.

Who is the listed applicant for iASSIST Knee System?

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

What is the FDA product code for iASSIST Knee System?

The FDA product code for iASSIST Knee System is OLO.

Other records listing Orthosoft 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.

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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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