Osseointegration Prosthetic Limb
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- 8mm Hex Clamp Screw EUDAMEDOsseointegration Prosthetic Limb FDA UDI
- Generic Name
- External lower-limb prosthesis structural/alignment component FDA UDI
- Device Name
- Lower Limb Connector EUDAMED8 mm Hex Clamp Screw FDA UDI
- Model / Reference
- OPL-LLC-C-S EUDAMED8 mm Hex Clamp Screw FDA UDI
- Description
- 8 mm Hex Clamp Screw FDA UDI
Identifiers
- Catalog Number
- OPL-LLC-C-S FDA UDI
- Primary DI / UDI-DI
- 19356371001121 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
Yes
Serial Number
No
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 27224807-a0d0-403d-b29d-3f16594d7298 34 fields · synced Jul 9, 2026
- EUDAMED ced72d7f-45ba-4cbb-a785-f2cd584af73c 61 fields · synced Jul 9, 2026