REDAPT Porous Acetabular Shell
K-Number: K181366 · 2018-09-24
ApplicantSmith & Nephew, Inc.
Decision Date2018-09-24
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
REDAPT Porous Acetabular Shell is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2018-09-24 under approval number K181366. 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 Porous Acetabular Shell?
REDAPT Porous Acetabular Shell is a medical device that received FDA 510(k) clearance on 2018-09-24. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K181366.
When was REDAPT Porous Acetabular Shell approved by the FDA?
REDAPT Porous Acetabular Shell received FDA 510(k) clearance on 2018-09-24, under approval number K181366.
What company makes REDAPT Porous Acetabular Shell?
REDAPT Porous Acetabular Shell is manufactured by Smith & Nephew, Inc..
What is the FDA product code for REDAPT Porous Acetabular Shell?
The FDA product code for REDAPT Porous Acetabular Shell is LPH.
Related Clinical Trials
Other Devices by Smith & Nephew, Inc.
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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.