Identity
- Trade Name
- Osseointegration Prosthetic Limb FDA UDI
- Generic Name
- External lower-limb prosthesis structural/alignment component FDA UDI
- Device Name
- 8 mm Hex Clamp Screw FDA UDI
- Model / Reference
- 8 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
- 19356371001046 FDA UDI
- FDA Product Code
- IQO FDA UDI
- GMDN Term
- External lower-limb prosthesis structural/alignment component FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3025 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: External lower-limb prosthesis structural/alignment component
Osseointegration Prosthetic Limb by Osseointegration International Pty Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Osseointegration International Pty Ltd
Sources (1)
- FDA UDI d98ac021-7f0e-4c31-93d4-f87cadda0f8e 34 fields · synced May 30, 2026