Identity
- Trade Name
- ENDURANCE FDA UDI
- Generic Name
- Polyethylene acetabulum prosthesis FDA UDI
- Device Name
- ENDURANCE ENDURON ACETABULAR CUP 20 DEGREE 28mm ID 44mm OD FDA UDI
- Model / Reference
- 1223-44-000 FDA UDI
- Description
- ENDURANCE ENDURON ACETABULAR CUP 20 DEGREE 28mm ID 44mm OD FDA UDI
Identifiers
- Catalog Number
- 122344000 FDA UDI
- Primary DI / UDI-DI
- 10603295016793 FDA UDI
- 510(k) Number
- K943696 FDA UDI
- FDA Product Code
- JDI FDA UDI
- GMDN Term
- Polyethylene acetabulum prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 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: Polyethylene acetabulum prosthesis
Endurance by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyethylene acetabulum prosthesis.
- ZCA® — Zimmer, Inc. · Class II
- Acetabular Insert — Howmedica Osteonics Corp. · Class II
- Cenator Total Hip System — CORIN LTD · Class II
- Exeter — Howmedica Osteonics Corp. · Class II
- Exeter — Howmedica Osteonics Corp. · Class II
- ZCA® — Zimmer, Inc. · Class II
- REFLECTION — Smith & Nephew, Inc. · Class II
- ZCA® — Zimmer, Inc. · Class II
Cleared under the same submission
K943696 also covers:
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 2bd31088-46ca-4174-af8f-5af29bd78382 36 fields · synced Jun 8, 2026