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

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

Microport Orthopedics, Inc.

The following data is part of a premarket notification filed by Microport Orthopedics, Inc. with the FDA for E-class® Dual Mobility Inserts And Dynasty® Dual Mobility Liners.

Pre-market Notification Details

• Device ID: K200011
• 510k Number: K200011
• Device Name: E-CLASS® DUAL MOBILITY INSERTS And DYNASTY® DUAL MOBILITY LINERS
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: Microport Orthopedics, Inc. 5677 Airline Road Arlington, TN 38002
• Contact: Kristen Russell
• Correspondent: Matthew Paul; Microport Orthopedics, Inc. 5677 Airline Road Arlington, TN 38002
• Product Code: LPH
• Subsequent Product Code: KWY
• Subsequent Product Code: LZO
• Subsequent Product Code: OQG
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-01-02
• Decision Date: 2021-10-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M684DLDMGJ521	K200011	000
M684DMNE28381	K200011	000
M684DLDMGK561	K200011	000
M684DLDMGJ541	K200011	000
M684DLDMGH501	K200011	000
M684DLDMGG461	K200011	000
M684DLDMGF441	K200011	000
M684DLDMGE421	K200011	000
M684DLDMGD401	K200011	000
M684DMNE28401	K200011	000
M684DMNE28421	K200011	000
M684DLDMGH481	K200011	000
M684DMNE28561	K200011	000
M684DMNE28541	K200011	000
M684DMNE28521	K200011	000
M684DMNE28501	K200011	000
M684DMNE28481	K200011	000
M684DMNE28461	K200011	000
M684DMNE28441	K200011	000
M684DLDMGC381	K200011	000