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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 a medical device manufactured by Polarisar, Inc.. It received FDA 510(k) clearance on 2023-11-02 under approval 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. It is manufactured by Polarisar, Inc.. The 510(k) number is K232176.

When was STELLAR Knee approved by the FDA?

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

What company makes STELLAR Knee?

STELLAR Knee is manufactured by Polarisar, Inc..

What is the FDA product code for STELLAR Knee?

The FDA product code for STELLAR Knee is SBF.

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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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