Identity
- Trade Name
- Dynasty FDA UDI
- Generic Name
- Metallic acetabular liner FDA UDI
- Device Name
- Dynasty® Dual Mobility Liner Group C 38mm FDA UDI
- Model / Reference
- DLDMGC38 FDA UDI
- Description
- Dynasty® Dual Mobility Liner Group C 38mm FDA UDI
Identifiers
- Catalog Number
- DLDMGC38 FDA UDI
- Primary DI / UDI-DI
- 00192629205536 FDA UDI
- 510(k) Number
- K200011 FDA UDI
- FDA Product Code
- OQG FDA UDIKWY FDA UDILZO FDA UDI
- GMDN Term
- Metallic acetabular liner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3390 FDA UDI888.3353 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Metallic acetabular liner
Dynasty by MicroPort Orthopedics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic acetabular liner.
- EMPHASYS — DEPUY (IRELAND) · Class II
- Micro Seal Shell — Signal Medical Corp. · Class II
- Micro Seal Shell — Signal Medical Corp. · Class II
- Logical Dual Mobility CoCr Liner — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- OR3O Dual Mobility — Smith & Nephew, Inc. · Class II
- EMPHASYS — DEPUY (IRELAND) · Class II
- Micro Seal Shell — Signal Medical Corp. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
Cleared under the same submission
K200011 also covers:
- Dynasty — MicroPort Orthopedics Inc.
- Dynasty — MicroPort Orthopedics Inc.
- Dynasty — MicroPort Orthopedics Inc.
- Dynasty — MicroPort Orthopedics Inc.
- Dynasty — MicroPort Orthopedics Inc.
- Dynasty — MicroPort Orthopedics Inc.
- Dynasty — MicroPort Orthopedics Inc.
- Dynasty — MicroPort Orthopedics Inc.
- Dynasty — MicroPort Orthopedics Inc.
- Dynasty — MicroPort Orthopedics Inc.
- Dynasty — MicroPort Orthopedics Inc.
- Dynasty — MicroPort Orthopedics Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- MicroPort Orthopedics Inc.
Sources (1)
- FDA UDI 0f5e113d-25ea-416a-a259-971662f358cf 36 fields · synced Jun 9, 2026