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Porous Sleeves
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 1511-01-106Model ATTUNE Revision Porous Sleeves
Identity
- Trade Name
- ATTUNE FDA UDI
- Generic Name
- Knee arthroplasty wedge FDA UDI
- Device Name
- Porous Sleeves EUDAMEDATTUNE KNEE SYSTEM REVISION FEMORAL SLEEVE POROCOAT PARTIALLY COATED 50MM FDA UDI
- Model / Reference
- ATTUNE Revision Porous Sleeves EUDAMED1511-01-106 EUDAMEDFDA UDI
- Description
- ATTUNE KNEE SYSTEM REVISION FEMORAL SLEEVE POROCOAT PARTIALLY COATED 50MM FDA UDI
Identifiers
- Catalog Number
- 151101106 FDA UDI
- Primary DI / UDI-DI
- 10603295436539 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a0044896 EUDAMED
- FDA Product Code
- MBH FDA UDIJWH FDA UDINJL FDA UDI
- EMDN Code
- P09098002 KNEE PROSTHESES ADAPTERS (INCLUDING CONES AND SLEEVES) EUDAMED
- GMDN Term
- Knee arthroplasty wedge FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3565 FDA UDI888.3560 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
MR Conditional FDA UDI
Category: Knee arthroplasty wedge
Porous Sleeves by DePuy Ireland UC — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Knee arthroplasty wedge.
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- LEGION — Smith & Nephew, Inc. · Class II
- ADVANTIM® — MicroPort Orthopedics Inc. · Class II
- LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KG · Class II
- Unity Total Knee System — CORIN LTD · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0603295a0044896 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED 1abb4dfb-9abe-4dfb-ad3a-df860b28831a 61 fields · synced Jul 17, 2026
- FDA UDI 35e9d03b-bf7a-4590-8b09-bb36255cd9e1 35 fields · synced May 30, 2026