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FDA 510(k)

R3 HA Coated Acetabular Shells

K-Number: K201701 · 2020-10-06

ApplicantSmith & Nephew, Inc.
Decision Date2020-10-06
Product CodeMBL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

R3 HA Coated Acetabular Shells is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2020-10-06 under approval number K201701. The device is classified under product code MBL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R3 HA Coated Acetabular Shells?

R3 HA Coated Acetabular Shells is a medical device that received FDA 510(k) clearance on 2020-10-06. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K201701.

When was R3 HA Coated Acetabular Shells approved by the FDA?

R3 HA Coated Acetabular Shells received FDA 510(k) clearance on 2020-10-06, under approval number K201701.

What company makes R3 HA Coated Acetabular Shells?

R3 HA Coated Acetabular Shells is manufactured by Smith & Nephew, Inc..

What is the FDA product code for R3 HA Coated Acetabular Shells?

The FDA product code for R3 HA Coated Acetabular Shells is MBL.

Related Clinical Trials

NCT02999009 Trident II Tritanium Acetabular Shell Outcomes Study ACTIVE_NOT_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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