FDA 510(k)

SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING

K-Number: K120211 · 2012-07-19

Decision Date2012-07-19

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING 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 2012-07-19 under 510(k) number K120211. 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 SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING?

SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING is a medical device that received FDA 510(k) clearance on 2012-07-19. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K120211.

When did SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING receive FDA 510(k) clearance?

SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING received FDA 510(k) clearance on 2012-07-19, under 510(k) number K120211.

Who is the listed applicant for SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING?

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 SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING?

The FDA product code for SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING 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.