Identity
- Trade Name
- DURALOC FDA UDI
- Generic Name
- Non-constrained polyethylene acetabular liner FDA UDI
- Device Name
- DURALOC ACETABULAR CUP SYSTEM MARATHON POLYETHYLENE ACETABULAR LINER +4 10 DEGREE 36mm ID 58/70mm OD FDA UDI
- Model / Reference
- 1220-36-558 FDA UDI
- Description
- DURALOC ACETABULAR CUP SYSTEM MARATHON POLYETHYLENE ACETABULAR LINER +4 10 DEGREE 36mm ID 58/70mm OD FDA UDI
Identifiers
- Catalog Number
- 122036558 FDA UDI
- Primary DI / UDI-DI
- 10603295015789 FDA UDI
- 510(k) Number
- K010171 FDA UDI
- FDA Product Code
- LPH FDA UDI
- GMDN Term
- Non-constrained polyethylene acetabular liner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 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 ACETABULAR CUP SYSTEM MARATHON POLYETHYLENE ACETABULAR LINER +4 10 DEGREE 36mm ID 58/70mm OD. A non-constrained polyethylene acetabular liner designed for use in total hip arthroplasty (THA), providing a durable and implantable component with limited range of motion.
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
- PRIME — MicroPort Orthopedics Inc. · 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
- Continuum® Trilogy® Allofit® Longevity® — Zimmer, Inc. · Class II
Cleared under the same submission
K010171 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 |
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Manufacturer
- Manufacturer
- Depuy Orthopaedics, Inc.
Sources (1)
- FDA UDI 30afebb7-0e8f-4437-aabe-0d603d6aa5c7 36 fields · synced Aug 2, 2026