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FDA 510(k)

STELLAR Knee

K-Number: K232176 · 2023-11-02

ApplicantPolarisar, Inc.
Decision Date2023-11-02
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STELLAR Knee is the device name listed in this FDA 510(k) record. The listed applicant is Polarisar, Inc.. It received FDA 510(k) clearance on 2023-11-02 under 510(k) number K232176. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STELLAR Knee?

STELLAR Knee is a medical device that received FDA 510(k) clearance on 2023-11-02. The listed applicant is Polarisar, Inc.. The 510(k) number is K232176.

When did STELLAR Knee receive FDA 510(k) clearance?

STELLAR Knee received FDA 510(k) clearance on 2023-11-02, under 510(k) number K232176.

Who is the listed applicant for STELLAR Knee?

The FDA 510(k) record lists Polarisar, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STELLAR Knee?

The FDA product code for STELLAR Knee is SBF.

Related Devices (Code: SBF)

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.

K261854xvision Spine systemAugmedics, Ltd.K253805Knee+Pixee Medical S.A.S.K252847NextAR Hip PlatformMedacta International S.A.K251639xvision Spine systemAugmedics, Ltd.K252054SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.K252530OptiVu™ ShoulderMr Surgical Solutions, LLC

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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