Osseointegration Prosthetic Limb
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Right Femoral Connector Assembly – M10 EUDAMEDOsseointegration Prosthetic Limb FDA UDI
- Generic Name
- External lower-limb prosthesis structural/alignment component FDA UDI
- Device Name
- Lower Limb Connector EUDAMEDRight Femoral Connector Assembly – M10 FDA UDI
- Model / Reference
- OPL-LLCM10-TF-R EUDAMEDM10 Grub Screw Right Connector FDA UDI
- Description
- Right Femoral Connector Assembly – M10 FDA UDI
Identifiers
- Catalog Number
- OPL-LLCM10-TF-R FDA UDI
- Primary DI / UDI-DI
- 19356371001022 EUDAMEDFDA UDI
- Basic UDI-DI
- 93563710OPL-LLCVF EUDAMED
- FDA Product Code
- IQO FDA UDI
- EMDN Code
- Y062499 LOWER EXTREMITY PROSTHESES - OTHER EUDAMED
- GMDN Term
- External lower-limb prosthesis structural/alignment component FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3025 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: External lower-limb prosthesis structural/alignment component
Osseointegration Prosthetic Limb by Osseointegration International Pty Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Osseointegration International Pty Ltd
Sources (2)
- FDA UDI 4cfca00c-b838-4fac-9231-585f62e9363b 34 fields · synced Jun 18, 2026
- EUDAMED 3f879b15-c982-42fe-801b-1d323e4bd100 61 fields · synced Jun 18, 2026