FDA 510(k)

TANDEM Hip System

K-Number: K231448 · 2023-07-19

Decision Date2023-07-19

Product CodeLZY

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TANDEM Hip System is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2023-07-19 under approval number K231448. The device is classified under product code LZY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TANDEM Hip System?

TANDEM Hip System is a medical device that received FDA 510(k) clearance on 2023-07-19. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K231448.

When was TANDEM Hip System approved by the FDA?

TANDEM Hip System received FDA 510(k) clearance on 2023-07-19, under approval number K231448.

What company makes TANDEM Hip System?

TANDEM Hip System is manufactured by Smith & Nephew, Inc..

What is the FDA product code for TANDEM Hip System?

The FDA product code for TANDEM Hip System is LZY.

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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.