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FDA 510(k)

REDAPT Sleeved Monolithic Revision Stems

K-Number: K162303 · 2017-05-01

ApplicantSmith & Nephew, Inc.
Decision Date2017-05-01
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REDAPT Sleeved Monolithic Revision Stems is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2017-05-01 under approval number K162303. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REDAPT Sleeved Monolithic Revision Stems?

REDAPT Sleeved Monolithic Revision Stems is a medical device that received FDA 510(k) clearance on 2017-05-01. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K162303.

When was REDAPT Sleeved Monolithic Revision Stems approved by the FDA?

REDAPT Sleeved Monolithic Revision Stems received FDA 510(k) clearance on 2017-05-01, under approval number K162303.

What company makes REDAPT Sleeved Monolithic Revision Stems?

REDAPT Sleeved Monolithic Revision Stems is manufactured by Smith & Nephew, Inc..

What is the FDA product code for REDAPT Sleeved Monolithic Revision Stems?

The FDA product code for REDAPT Sleeved Monolithic Revision Stems is MEH.

Related Clinical Trials

NCT06788717 MDR - Comprehensive Primary Revision Stems PMCF RECRUITING

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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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