Identity
- Trade Name
- DURALOC FDA UDI
- Generic Name
- Constrained polyethylene acetabular liner FDA UDI
- Device Name
- DURALOC ACETABULAR CUP SYSTEM CONSTRAINED LINER 28mm ID 52mm OD FDA UDI
- Model / Reference
- 1241-12-527 FDA UDI
- Description
- DURALOC ACETABULAR CUP SYSTEM CONSTRAINED LINER 28mm ID 52mm OD FDA UDI
Identifiers
- Catalog Number
- 124112527 FDA UDI
- Primary DI / UDI-DI
- 10603295018674 FDA UDI
- PMA Number
- P960054 FDA UDI
- FDA Product Code
- KWZ FDA UDI
- GMDN Term
- Constrained polyethylene acetabular liner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3310 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: 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 Constrained polyethylene acetabular liner.
- Omnifit — Howmedica Osteonics Corp. · Class II
- Trilogy® — Zimmer, Inc. · Class II
- Trident — Howmedica Osteonics Corp. · Class II
- System 12 — Howmedica Osteonics Corp. · Class II
- Trabecular Metal® Acetabular Revision System — Zimmer, Inc. · Class II
- Omnifit — Howmedica Osteonics Corp. · Class II
- G7® Freedom® Vivacit-E® — Zimmer, Inc. · Class II
- System 12 — Howmedica Osteonics Corp. · Class II
Cleared under the same submission
P960054 also covers:
- DURALOC — DEPUY ORTHOPAEDICS, INC.
- DURALOC — DEPUY ORTHOPAEDICS, INC.
- DURALOC — DEPUY ORTHOPAEDICS, INC.
- DURALOC — DEPUY ORTHOPAEDICS, INC.
- DURALOC — DEPUY ORTHOPAEDICS, INC.
- DURALOC — DEPUY ORTHOPAEDICS, INC.
- DURALOC — DEPUY ORTHOPAEDICS, INC.
- DURALOC — DEPUY ORTHOPAEDICS, INC.
- DURALOC — DEPUY ORTHOPAEDICS, INC.
- DURALOC — DEPUY ORTHOPAEDICS, INC.
- 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 1a2bf572-cbb3-4d31-b2de-060ffe7fae2e 37 fields · synced Jun 8, 2026