FDA 510(k)

POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA

K-Number: K130728 · 2013-10-10

Decision Date2013-10-10

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2013-10-10 under 510(k) number K130728. 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 STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA?

POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA is a medical device that received FDA 510(k) clearance on 2013-10-10. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K130728.

When did POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA receive FDA 510(k) clearance?

POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA received FDA 510(k) clearance on 2013-10-10, under 510(k) number K130728.

Who is the listed applicant for POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA?

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

What is the FDA product code for POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA?

The FDA product code for POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA is LZO.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.