Smith & Nephew, Inc. REDAPT Augments
K-Number: K171073 · 2017-11-21
ApplicantSmith & Nephew, Inc.
Decision Date2017-11-21
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Smith & Nephew, Inc. REDAPT Augments is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2017-11-21 under approval number K171073. 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 Smith & Nephew, Inc. REDAPT Augments?
Smith & Nephew, Inc. REDAPT Augments is a medical device that received FDA 510(k) clearance on 2017-11-21. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K171073.
When was Smith & Nephew, Inc. REDAPT Augments approved by the FDA?
Smith & Nephew, Inc. REDAPT Augments received FDA 510(k) clearance on 2017-11-21, under approval number K171073.
What company makes Smith & Nephew, Inc. REDAPT Augments?
Smith & Nephew, Inc. REDAPT Augments is manufactured by Smith & Nephew, Inc..
What is the FDA product code for Smith & Nephew, Inc. REDAPT Augments?
The FDA product code for Smith & Nephew, Inc. REDAPT Augments 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.