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FDA 510(k)

POLARSTEM Cemented Femoral Stem

K-Number: K203175 · 2021-07-22

ApplicantSmith & Nephew, Inc.
Decision Date2021-07-22
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

POLARSTEM Cemented Femoral Stem is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2021-07-22 under approval number K203175. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLARSTEM Cemented Femoral Stem?

POLARSTEM Cemented Femoral Stem is a medical device that received FDA 510(k) clearance on 2021-07-22. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K203175.

When was POLARSTEM Cemented Femoral Stem approved by the FDA?

POLARSTEM Cemented Femoral Stem received FDA 510(k) clearance on 2021-07-22, under approval number K203175.

What company makes POLARSTEM Cemented Femoral Stem?

POLARSTEM Cemented Femoral Stem is manufactured by Smith & Nephew, Inc..

What is the FDA product code for POLARSTEM Cemented Femoral Stem?

The FDA product code for POLARSTEM Cemented Femoral Stem is LZO.

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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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