Identity
- Trade Name
- DURALOC FDA UDI
- Generic Name
- Non-constrained polyethylene acetabular liner FDA UDI
- Device Name
- DURALOC ACETABULAR CUP SYSTEM ENDURON BANTAM ACETABULAR LINER 10 DEGREE 22.225mm ID 40mm OD FDA UDI
- Model / Reference
- 1241-40-526 FDA UDI
- Description
- DURALOC ACETABULAR CUP SYSTEM ENDURON BANTAM ACETABULAR LINER 10 DEGREE 22.225mm ID 40mm OD FDA UDI
Identifiers
- Catalog Number
- 124140526 FDA UDI
- Primary DI / UDI-DI
- 10603295018926 FDA UDI
- FDA Product Code
- HSX FDA UDIJWH FDA UDIKWT FDA UDIJDI FDA UDILPH FDA UDIHRY FDA UDIJDB FDA UDI
- GMDN Term
- Non-constrained polyethylene acetabular liner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3520 FDA UDI888.3560 FDA UDI888.3650 FDA UDI888.3350 FDA UDI888.3358 FDA UDI888.3530 FDA UDI888.3160 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
No
FDA UDI
Category: Non-constrained polyethylene acetabular liner
Duraloc by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-constrained polyethylene acetabular liner.
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- G7 Acetabular Liner — Biomet Orthopedics, Inc. · Class II
- Logical 20° Hooded Liner — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
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Cleared under the same submission
K944538 also covers:
- AMK — DEPUY ORTHOPAEDICS, INC.
- AMK — DEPUY ORTHOPAEDICS, INC.
- AMK — DEPUY ORTHOPAEDICS, INC.
- AMK — DEPUY ORTHOPAEDICS, INC.
- AMK — DEPUY ORTHOPAEDICS, INC.
- AMK — DEPUY ORTHOPAEDICS, INC.
- AMK — DEPUY ORTHOPAEDICS, INC.
- AMK — DEPUY ORTHOPAEDICS, INC.
- AMK — DEPUY ORTHOPAEDICS, INC.
- AMK — DEPUY ORTHOPAEDICS, INC.
- AMK — DEPUY ORTHOPAEDICS, INC.
- AMK — DEPUY ORTHOPAEDICS, INC.
K961186 also covers:
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY ORTHOPAEDICS, INC.
- DURALOC — DEPUY ORTHOPAEDICS, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Depuy Orthopaedics, Inc.
Sources (1)
- FDA UDI 2771b731-2de2-4b3a-891e-df2a85142f32 36 fields · synced Jun 8, 2026