Identity
- Trade Name
- DURAMER® FDA UDI
- Generic Name
- Non-constrained polyethylene acetabular liner FDA UDI
- Device Name
- DURAMER® ACETABULAR SHELL LINER SIZE I 28mm 10 DEGREE FDA UDI
- Model / Reference
- 20102856 FDA UDI
- Description
- DURAMER® ACETABULAR SHELL LINER SIZE I 28mm 10 DEGREE FDA UDI
Identifiers
- Catalog Number
- 20102856 FDA UDI
- Primary DI / UDI-DI
- M684201028561 FDA UDI
- FDA Product Code
- KXA FDA UDI
- GMDN Term
- Non-constrained polyethylene acetabular liner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3400 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
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 28 Millimeter FDA UDI
Category: Non-constrained polyethylene acetabular liner
Duramer® by MicroPort Orthopedics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-constrained polyethylene acetabular liner.
- C-Fit & DC-Fit Acetabular Cup System — CORIN LTD · Class II
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- MobileLink Acetabular Cup System — WALDEMAR LINK GmbH & Co. KG · Class II
- G7 Acetabular Liner — Biomet Orthopedics, Inc. · Class II
- Logical 20° Hooded Liner — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- RINGLOC RX90-2 HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- PINNACLE — DEPUY ORTHOPAEDICS, INC. · Class II
- Continuum® Trilogy® Allofit® Longevity® — Zimmer, Inc. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MicroPort Orthopedics Inc.
Sources (1)
- FDA UDI 2660808f-2780-48c1-bf13-02aabc050f6f 36 fields · synced Jun 9, 2026