Identity
- Trade Name
- Wedge | Acute Knee | Large EUDAMEDBoneFoam FDA UDI
- Generic Name
- Freestanding patient positioner, reusable FDA UDI
- Device Name
- Wedge | Acute Knee | Large EUDAMEDFDA UDI
- Model / Reference
- 925.AAKWL EUDAMEDFDA UDI
- Description
- Wedge | Acute Knee | Large FDA UDI
Identifiers
- Catalog Number
- 925.AAKWL FDA UDI
- Primary DI / UDI-DI
- 00810075280302 EUDAMEDFDA UDI
- Basic UDI-DI
- 081007528925AAKWLKE EUDAMED
- Direct Marketing DI
- 00810075280302 EUDAMED
- FDA Product Code
- CCX FDA UDI
- EMDN Code
- V080302 PATIENT POSITIONING MEDICAL CUSHIONS EUDAMED
- GMDN Term
- Freestanding patient positioner, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.6820 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Height — 19.32 Inch FDA UDIWidth — 12 Inch FDA UDI
Wedge | Acute Knee | Large by Bone Foam, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 081007528925AAKWLKE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bone Foam, Inc.
- EUDAMED SRN
- US-MF-000035043
- Authorised Representative
- Bone Foam B.V. NL-AR-000035735
Sources (2)
- EUDAMED 7d3ac123-5e78-4e89-8180-0ebdf2ff8063 61 fields · synced Jul 18, 2026
- FDA UDI 20c7537b-cce3-4a11-964f-77aa6622e31c 35 fields · synced May 30, 2026