Smith & Nephew, Inc. R3 Constrained Liner
K-Number: K162641 · 2017-06-19
ApplicantSmith & Nephew, Inc.
Decision Date2017-06-19
Product CodeKWZ
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Smith & Nephew, Inc. R3 Constrained Liner is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2017-06-19 under approval number K162641. The device is classified under product code KWZ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Smith & Nephew, Inc. R3 Constrained Liner?
Smith & Nephew, Inc. R3 Constrained Liner is a medical device that received FDA 510(k) clearance on 2017-06-19. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K162641.
When was Smith & Nephew, Inc. R3 Constrained Liner approved by the FDA?
Smith & Nephew, Inc. R3 Constrained Liner received FDA 510(k) clearance on 2017-06-19, under approval number K162641.
What company makes Smith & Nephew, Inc. R3 Constrained Liner?
Smith & Nephew, Inc. R3 Constrained Liner is manufactured by Smith & Nephew, Inc..
What is the FDA product code for Smith & Nephew, Inc. R3 Constrained Liner?
The FDA product code for Smith & Nephew, Inc. R3 Constrained Liner is KWZ.
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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.