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FDA 510(k)

REDAPT Modular Acetabular Shell

K-Number: K182109 · 2018-11-16

ApplicantSmith & Nephew, Inc.
Decision Date2018-11-16
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REDAPT Modular Acetabular Shell is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2018-11-16 under approval number K182109. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REDAPT Modular Acetabular Shell?

REDAPT Modular Acetabular Shell is a medical device that received FDA 510(k) clearance on 2018-11-16. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K182109.

When was REDAPT Modular Acetabular Shell approved by the FDA?

REDAPT Modular Acetabular Shell received FDA 510(k) clearance on 2018-11-16, under approval number K182109.

What company makes REDAPT Modular Acetabular Shell?

REDAPT Modular Acetabular Shell is manufactured by Smith & Nephew, Inc..

What is the FDA product code for REDAPT Modular Acetabular Shell?

The FDA product code for REDAPT Modular Acetabular Shell is LPH.

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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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