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FDA 510(k)

E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS

K-Number: K200011 · 2021-10-01

ApplicantMicroport Orthopedics, Inc.
Decision Date2021-10-01
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS is a medical device manufactured by Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2021-10-01 under approval number K200011. 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 E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS?

E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS is a medical device that received FDA 510(k) clearance on 2021-10-01. It is manufactured by Microport Orthopedics, Inc.. The 510(k) number is K200011.

When was E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS approved by the FDA?

E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS received FDA 510(k) clearance on 2021-10-01, under approval number K200011.

What company makes E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS?

E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS is manufactured by Microport Orthopedics, Inc..

What is the FDA product code for E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS?

The FDA product code for E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS is LPH.

Related Clinical Trials

NCT07607899 Virtual Reality for Pain and Well-Being in Older Adults NOT_YET_RECRUITING NCT06627361 Comparative Study Evaluating the Mobility of Transtibial Amputee Patients Using the PRO-FLEX PIVOT® Foot Versus a Class III Energy Storing and Returning (ESAR) Prosthetic Foot. COMPLETED

Other Devices by Microport Orthopedics, Inc.

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Related Devices (Code: 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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