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CoreLink Foundation 3D ALIF Stand-Alone Lock Assembly
FDA UDIClass II (US FDA UDI)
by Corelink Llc
Identity
- Trade Name
- CoreLink Foundation 3D ALIF Stand-Alone Lock Assembly FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Foundation 3D Stand-Alone ALIF, Lock Assembly FDA UDI
- Model / Reference
- LK300-1000 FDA UDI
- Description
- Foundation 3D Stand-Alone ALIF, Lock Assembly FDA UDI
Identifiers
- Primary DI / UDI-DI
- M725LK3001000 FDA UDI
- FDA Product Code
- OVD FDA UDI
- GMDN Term
- Spinal fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Spinal fixation plate, non-bioabsorbable
CoreLink Foundation 3D ALIF Stand-Alone Lock Assembly by Corelink Llc — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Corelink Llc
Sources (1)
- FDA UDI 4a92c3be-ac08-4f61-9d58-5138aef92860 34 fields · synced Jun 1, 2026