Dynasty DMNE2852

GUDID M684DMNE28521

E-Class® Dual Mobility Insert 28MM ID 52MM OD

Microport Orthopedics Inc.

Non-constrained polyethylene acetabular liner

• Primary Device ID: M684DMNE28521
• NIH Device Record Key: f07e6882-5771-4376-a4f4-7a17028deb4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dynasty
• Version Model Number: DMNE2852
• Catalog Number: DMNE2852
• Company DUNS: 079118736
• Company Name: Microport Orthopedics Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192629235632 [Primary]
HIBCC	M684DMNE28521 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200011

FDA Product Code

• KWY: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-15
• Device Publish Date: 2021-10-07

On-Brand Devices [Dynasty]

• M684DMBPRESS1: Dual Mobility Arbor Press Base
• M68433DMGJ521: Dynasty® Dual Mobility Trial Liner Group J 52mm
• M68433DMGH481: Dynasty® Dual Mobility Trial Liner Group H 48mm
• M684DLDMGJ521: Dynasty® Dual Mobility Liner Group J 52mm
• M684DLDMGH481: Dynasty® Dual Mobility Liner Group H 48mm
• M68433DMGK561: Dynasty® Dual Mobility Trial Liner Group K 56mm
• M68433DMGJ541: Dynasty® Dual Mobility Trial Liner Group J 54mm
• M68433DMGH501: Dynasty® Dual Mobility Trial Liner Group H 50mm
• M68433DMGG461: Dynasty® Dual Mobility Trial Liner Group G 46mm
• M68433DMGF441: Dynasty® Dual Mobility Trial Liner Group F 44mm
• M68433DMGE421: Dynasty® Dual Mobility Trial Liner Group E 42mm
• M68433DMGD401: Dynasty® Dual Mobility Trial Liner Group D 40mm
• M68433DMGC381: Dynasty® Dual Mobility Trial Liner Group C 38mm
• M684DMNT28561: Dual Mobility Insert Trial 28MM ID 56MM OD
• M684DMNT28541: Dual Mobility Insert Trial 28MM ID 54MM OD
• M684DMNT28521: Dual Mobility Insert Trial 28MM ID 52MM OD
• M684DMNT28501: Dual Mobility Insert Trial 28MM ID 05MM OD
• M684DMNT28481: Dual Mobility Insert Trial 28MM ID 48MM OD
• M684DMNT28461: Dual Mobility Insert Trial 28MM ID 46MM OD
• M684DMNT28441: Dual Mobility Insert Trial 28MM ID 44MM OD
• M684DMNT28421: Dual Mobility Insert Trial 28MM ID 42MM OD
• M684DMNT28401: Dual Mobility Insert Trial 28MM ID 40MM OD
• M684DMNT28381: Dual Mobility Insert Trial 28MM ID 38MM OD
• M684DMAPRESS1: Dual Mobility Arbor Press
• M684DMNE28561: E-Class® Dual Mobility Insert 28MM ID 56MM OD
• M684DMNE28541: E-Class® Dual Mobility Insert 28MM ID 54MM OD
• M684DMNE28521: E-Class® Dual Mobility Insert 28MM ID 52MM OD
• M684DMNE28501: E-Class® Dual Mobility Insert 28MM ID 50MM OD
• M684DMNE28481: E-Class® Dual Mobility Insert 28MM ID 48MM OD
• M684DMNE28461: E-Class® Dual Mobility Insert 28MM ID 46MM OD
• M684DMNE28441: E-Class® Dual Mobility Insert 28MM ID 44MM OD
• M684DMNE28421: E-Class® Dual Mobility Insert 28MM ID 42MM OD
• M684DMNE28401: E-Class® Dual Mobility Insert 28MM ID 40MM OD
• M684DMNE28381: E-Class® Dual Mobility Insert 28MM ID 38MM OD
• M684DLDMGK561: Dynasty® Dual Mobility Liner Group K 56mm
• M684DLDMGJ541: Dynasty® Dual Mobility Liner Group J 54mm
• M684DLDMGH501: Dynasty® Dual Mobility Liner Group H 50mm
• M684DLDMGG461: Dynasty® Dual Mobility Liner Group G 46mm
• M684DLDMGF441: Dynasty® Dual Mobility Liner Group F 44mm
• M684DLDMGE421: Dynasty® Dual Mobility Liner Group E 42mm
• M684DLDMGD401: Dynasty® Dual Mobility Liner Group D 40mm
• M684DLDMGC381: Dynasty® Dual Mobility Liner Group C 38mm
• M684DLXPLG401: Dynasty® A-Class 40mm 15DG Group G Crosslinked Poly Liner
• M684DLXPGG401: Dynasty® A-Class 40mm STD Group G Crosslinked Poly Liner
• M684DLXPLK441: Dynasty® A-Class 44mm 15DG Group K Crosslinked Poly Liner
• M684DLXPGK441: Dynasty® A-Class 44mm STD Group K Crosslinked Poly Liner
• M684DLXPLJ441: Dynasty® A-Class 44mm 15DG Group J Crosslinked Poly Liner
• M684DLXPGJ441: Dynasty® A-Class 44mm STD Group J Crosslinked Poly Liner
• M684DLXPLH441: Dynasty® A-Class 44mm 15DG Group H Crosslinked Poly Liner
• M6843304LK441: Dynasty® 15DG Poly Trial Liner Group K 44mm